<h3>Job Description</h3>
Highlights
<ul>
<li>$55,000 - $70,000 salary based on experience and certifications </li>
<li>Consistent schedule M-F, no overnights or weekends</li>
<li>Work with a company that truly cares about their employees and patients</li>
</ul>
 
About Our Client
Our client is a long standing clinical research site in the Columbus, OH area that takes a truly unique patient-centric, service-oriented, approach to clinical research. Their reputation for excellence has been built across over 20 therapeutic areas, over 15 physicians, and over 550 completed trials! They are looking to expand their team with a skilled clinical research coordinator!
 
Responsibilities
As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process!
 
<ul>
<li>Conduct procedures such as vital signs, blood draws, EKGs, and bladder scans.</li>
<li>Patient recruitment, enrollment, scheduling, and consent</li>
<li>Lab procedures and shipments</li>
<li>Maintain GCP and follow protocols</li>
<li>Data management in EDC systems</li>
<li>Overall coordination of the study</li>
</ul>
 
Qualifications:
<ul>
<li>Clinical research experience as a Research Assistant OR as a CRC </li>
<li>Phlebotomy and lab processing experience (ability to perform without supervision)</li>
<li>Ability to work on site M-F on site (there is no remote or hybrid days)</li>
</ul>

Clinical Research Coordinator

<h3>Job Description</h3>
Highlights
<ul>
<li>$65,000 - $85,000 salary based on experience and certifications </li>
<li>Consistent schedule M-F, no overnights or weekends</li>
<li>Work with a company that truly cares about their employees and patients</li>
</ul>
 
About Our Client
Our client is a long standing clinical research site in the Columbus, OH area that takes a truly unique patient-centric, service-oriented, approach to clinical research. Their reputation for excellence has been built across over 20 therapeutic areas, over 15 physicians, and over 550 completed trials! They are looking to expand their team with a skilled clinical research Nurse coordinator!
 
Responsibilities
As a Clinical Research Nurse, you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process!
 
<ul>
<li>Conduct procedures such as vital signs, blood draws, EKGs, and bladder scans.</li>
<li>Patient recruitment, enrollment, scheduling, and consent</li>
<li>Lab procedures and shipments</li>
<li>Maintain GCP and follow protocols</li>
<li>Data management in EDC systems</li>
<li>Overall coordination of the study</li>
</ul>
 
Qualifications:
<ul>
<li>Clinical research experience required </li>
<li>RN license </li>
<li>Ability to work on site M-F on site (there is no remote or hybrid days)</li>
</ul>

Clinical Research Nurse

<h3>Job Description</h3>
Job Description
This is a remote position.
The Clinical Project Manager (CPM) is responsible for leading and managing all aspects of clinical trials from initiation through closeout. This includes ensuring that clinical projects are conducted in compliance with applicable regulatory requirements, company SOPs, timelines, and budget. The CPM will serve as the primary point of contact for cross-functional teams, vendors, and sponsors (if applicable), ensuring streamlined communication and timely issue resolution throughout the project lifecycle. Key Responsibilities: Develop, manage, and oversee clinical trial project plans including timelines, milestones, budgets, and resource allocation. Serve as the primary liaison between internal teams, clinical research sites, CROs, vendors, and external partners. Lead cross-functional team meetings and coordinate study activities such as site selection, study start-up, monitoring, and close-out. Ensure adherence to GCP, ICH guidelines, regulatory standards, and company SOPs throughout study conduct. Monitor progress against timelines and budget; proactively identify risks and implement mitigation strategies. Oversee vendor performance and manage contract deliverables for CROs, central labs, data management providers, etc. Track clinical trial metrics and prepare regular status reports for internal leadership and/or sponsors. Support regulatory and audit readiness, including contributing to study documentation and inspection preparation. Participate in protocol development, CRF design, and review of key trial documents (e.g., ICF, SAP, CSR). Minimum Qualifications: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (Master’s or PMP certification a plus). Minimum of 5 years of experience in clinical research, including 2+ years in a project management role. Strong understanding of GCP, ICH guidelines, and clinical trial regulatory requirements. Proven ability to manage multi-site and/or global studies across various phases (Phase I–IV). Excellent organizational, problem-solving, and leadership skills. Strong interpersonal and written communication skills. Proficiency with clinical trial management systems (CTMS), MS Project, and Microsoft Office Suite. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.

Clinical Project Manager

<h3>Job Description</h3>
Job Description
This is a remote position.
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements. This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution. Key Responsibilities: Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol. Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines. Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams. Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations. Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP). Manage database lock activities and contribute to the preparation of clinical study reports (CSRs). Serve as the primary point of contact for data management vendors and oversee their deliverables. Participate in study team meetings and provide status updates related to data quality and timelines. Support audit readiness and participate in regulatory inspections when required. Minimum Qualifications: Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field. Advanced degree is a plus. Minimum of 3–5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment. Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap). Strong understanding of ICH-GCP, FDA regulations, and CDISC standards. Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug). Excellent organizational, analytical, and problem-solving skills. Strong communication and collaboration skills across cross-functional teams. Experience working on global, multi-site clinical trials preferred. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.

Clinical Data Manager

<h3>Job Description</h3>
Job Description
Our client is seeking a Senior Clinical Project Manager / Associate Director, Clinical Operations to lead the clinical operations for their early-phase celiac disease trial. This role offers the opportunity to manage a CRO team, oversee study timelines and budgets, and contribute to protocol design and trial strategy. The position is remote-friendly, reports to the CMO, and provides a clear path to grow into a Director of Clinical Operations as the company’s pipeline expands post-merger. Ideal candidates have experience leading teams at CROs, managing early-phase studies, and driving complex clinical programs to deliver results.
 
Main purpose of the job:
To assist with the clinical activities to support our clients’ portfolio of research and development projects. All activities carried out with regard to time, cost, and quality, and in accordance with SOPs, ICH/ GCP guidelines, and local regulations.
 
Key responsibilities include:
<ul>
<li>Management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant guidelines, and all applicable laws and regulations.</li>
<li>Study team coordination and leadership.</li>
<li>Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality.</li>
<li>Responsibility for the preparation of study documentation and coordination of document review, e.g., protocols, IBs, DSURs, ICFs, CSRs.</li>
<li>Selection and oversight of assigned CROs, vendors, or contract monitors (CRAs), as appropriate.</li>
<li>Selection of suitable clinical sites in collaboration with other members of the Barinthus study team or CROs, as appropriate.</li>
<li>Periodic co-­‐monitoring with contract CRAs or CROs as necessary for each study, to ensure high-quality monitoring and site management.</li>
<li>Set up and management of clinical contracts (including Clinical Site Agreements).</li>
<li>Coordination of IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions.</li>
<li>Preparation of study budgets, forecasting, and accruals.</li>
<li>Thorough documentation of study team activities, decisions, actions, and risk assessments.</li>
<li>Active management of clinical trials supply requirements in collaboration with 3rd party storage &amp; distribution specialists.</li>
<li>Oversight of Sponsor Oversight File and/or TMF creation and maintenance by Clinical Trial Administrator, to ensure ‘inspection-­‐ readiness’ of documentation at all times.</li>
<li>Active acquisition and furthering of therapeutic area knowledge appropriate to assigned studies.</li>
<li>Assist with departmental development work, e.g., SOP review/writing and process improvements initiatives.</li>
<li>Develop and maintain relations with sites and KOLs.</li>
</ul>
 
Other Responsibilities of the Role:
Personal abilities and traits:
<ul>
<li>Demonstrates personal drive and goal orientation.</li>
<li>Self-motivated, taking personal pride in delivering on personal and corporate objectives.</li>
<li>Enthusiastic and flexible to change.</li>
<li>Demonstrates strong organisational and prioritisation skills to manage a diverse workload.</li>
<li>Able to interact with individuals at all levels of the organisation.</li>
<li>A highly effective communicator, both orally and in writing, with an eye for detail/ accuracy.</li>
<li>Reliable and trustworthy, able to work with minimal supervision.</li>
</ul>
 
Qualifications and/or experience required to perform the role
Essential knowledge, experience, and skills:
<ul>
<li>BSc or equivalent.</li>
<li>Clinical study management experience within a pharmaceutical, biotech, or CRO company.</li>
<li>Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc).</li>
<li>Excellent written and verbal communication and presentation skills.</li>
<li>Excellent organisational and interpersonal skills.</li>
<li>Ability to manage multiple priorities within one or across different projects.</li>
<li>Excellent working knowledge of GCP and current clinical trial legislation.</li>
<li>Thorough knowledge of the clinical development process, ideally from first-in-human through to regulatory filing for marketing.</li>
<li>Ability to travel in the USA and abroad periodically if needed.</li>
<li>Ability to work in a dynamic small team environment.</li>
</ul>
 
Desired skills:
<ul>
<li>Experience in early phase (I-­‐II) studies.</li>
<li>Working with GMO experience.</li>
<li>CRA/monitoring experience.</li>
<li>Experience of EDC and eTMF; comfortable with electronic systems, e.g., CTMS.</li>
<li>Autoimmune Diseases and Immunology experience.</li>
</ul>

Sr. Clinical Project Manager / Associate Director, Clinical Operations

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $95,000 
We are looking for an experienced Clinical Operations Manager II to join our team! 
 
Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!

This role serves as the primary point of contact for industry sponsored clinical trials, Endpoint and Specialty Services activities and also provides operational support for biostatistics and programming deliverables.
 
Remote candidates are welcome to apply.

In this position you will:
<ul>
<li>Oversee clinical operations management activities.</li>
<li>Define and monitor project scope, timelines and deliverables from project initiation to close-out.</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Oversee trial-related activities.</li>
<li>Track and approve vendor payments.</li>
<li>Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates.</li>
<li>Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.</li>
<li>Ensure the overall quality of project services and deliverables.</li>
<li>Provide necessary updates and reports to the sponsor as outlined by the contract.</li>
<li>Plan and oversee the execution of investigator meetings as contracted.</li>
<li>Work with the Business Development team on budgets, proposals and change orders.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.</li>
<li>Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.</li>
<li>Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li>Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li>Oversee SAE process and assure execution of safety plans.</li>
<li>Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites.</li>
<li>Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li>Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li>Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li>Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.</li>
<li>Provide operational support for the biostatistics and programming deliverables.</li>
</ul>
 
Heres what you will need to bring to the table:
<ul>
<li>Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).</li>
<li>4 years of experience in a clinical research setting, preferably with at least 2 years of project/operations management experience in clinical research.</li>
<li>Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li>Excellent communication and organizational skills.</li>
<li>Great attention to detail.</li>
<li>Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.</li>
<li>Ability to organize, instruct and oversee project staff, while promoting group effort and achievement.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel 20-25%.</li>
</ul>
 
Note:Viable applicants will be required to pass a background and education verification check.
 
Targeted Compensation: $72,000 - $95,000 annually
 
Deadline to Apply: December 1, 2025

About CPC:
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas.With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>

CPC offers:
<ul>
<li>Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li>Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li>11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li>Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li>Flexible and remote work schedules</li>
</ul>
 
An Equal Opportunity Employer
 
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.

Clinical Operations Manager II

<h3>Job Description</h3>
Job Description
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit <a href="http://www.CareAccess.com" target="_blank">www.CareAccess.com</a>.
How This Role Makes a Difference
Care Access Research is currently looking to hire a full time, remote, Clinical Vendor Activation Manager. The Clinical Vendor Activation Manager serves as a dedicated resource within the Study Start Up Department (SSU) to oversee vendor engagement during clinical trial start-up and execution. This role ensures vendors are qualified, contracted, and aligned with study protocols and activation timelines. The Clinical Vendor Activation Manager combines operational vendor oversight with clinical insight, enabling Care Access to activate studies on time and support the site network effectively. 
How You'll Make An Impact
Clinical protocol review and vendor needs identification
<ul>
<li>Review clinical protocols and study documents to determine vendor scope and compatibility; translate protocol elements into vendor qualifications and expectations.</li>
</ul>
Clinical consultation for vendor qualification
<ul>
<li>Provide clinical insight to the Vendor Management and SSU teams to support vendor selection, feasibility, and site alignment. </li>
</ul>
<ul>
<li>Collaborate with SSU, Regulatory, Site Ops, Legal, Vendor Management, and other departments to align on vendor strategy, timelines, and documentation flow.</li>
</ul>
Vendor onboarding and issue escalation
<ul>
<li>Guide vendors through training expectations based on protocol requirements; assist internal teams in clarifying procedural expectations and documentation needs. </li>
</ul>
<ul>
<li>Identify and troubleshoot vendor-related issues impacting clinical execution or study timelines; act as clinical escalation point for vendor readiness concerns.</li>
</ul>
Clinical support during SEV and site activation 
<ul>
<li>Participate in SEV preparation and vendor-related activation readiness, ensuring clinical requirements are addressed early in the start-up process, with an 'outside-the-box' mindset to identify creative solutions with sites and managers to meet deliverables </li>
</ul>
Other Responsibilities
<ul>
<li>Serve as the clinical point-of-contact for vendors, ensuring timely responses when study manuals are unavailable.</li>
<li>Standardize and improve communication pathways between vendors, SSU teams, and internal stakeholders.</li>
<li>Monitor vendor performance, proactively raise risks based on historical knowledge, and escalate concerns impacting KPIs.</li>
<li>Document and track contracting and qualification timelines, escalation history, and vendor performance metrics in internal systems</li>
<li>Support relationship-building with vendors, sponsors, site networks, and investigators by ensuring consistent, high-quality messaging.</li>
<li>Develop and refine vendor management processes to optimize efficiency and quality.</li>
<li>Contribute to pipeline planning by maintaining accurate vendor historical records and lessons learned.</li>
<li>Apply data management skills to track KPIs and ensure compliance with site network requirements.</li>
<li>Negotiate with vendors and sponsors, demonstrating sales ability when communicating the benefits of partnering with Care Access.</li>
<li>Maintain vendor documentation, records of communications, and escalation logs.</li>
<li>Represent Vendor Management in clinical and operational discussions with sponsors, CROs, and vendor teams.</li>
<li>Guide internal and external stakeholders on vendor requirements, protocol expectations, training, and procedures.</li>
<li>Participate in governance calls and internal meetings to provide updates on vendor performance and risk status.</li>
<li>Develop tools, templates, and training materials to strengthen vendor onboarding and oversight processes.</li>
<li>Oversee vendor relationships, ensuring compliance with company policies, service level agreements, and performance standards.</li>
<li>Review, negotiate, and manage contracts throughout their lifecycle, including renewals and amendments.</li>
<li>Monitor vendor performance, resolve escalations, and recommend improvements to optimize cost, quality, and service.</li>
</ul>
The Expertise Required
<ul>
<li>Strong understanding of clinical protocols, trial execution, and start-up workflows. </li>
<li>Prior vendor experience with the ability to discuss protocol clinical aspects with vendors. </li>
<li>Skilled at guiding vendor partners and internal teams on protocol expectations, training, and procedures. </li>
<li>Effective communicator of vendor requirements both internally and externally. </li>
<li>Experience interacting with sponsors and their preferred vendor teams to review expectations and qualifications. </li>
<li>Experience working with site networks; direct site-based experience strongly valued. </li>
<li>Ability to negotiate and 'sell' Care Access's value to vendor partners and sponsors. </li>
<li>Experience interacting with investigators, clinical staff, and site teams to support operational decision-making. </li>
<li>Strong cross-functional communication skills in a fast-paced, matrixed environment. </li>
<li>Creative, outside-the-box problem solving with openness to brainstorming solutions. </li>
<li>Proactive mindset with ownership, accountability, and focus on clinical quality. </li>
<li>Ability to foresee risks based on historical knowledge, manage escalations efficiently, and follow up across governance structures. </li>
<li>Data management skills for tracking KPIs, vendor performance, and escalation logs. </li>
<li>Ability to hold vendors accountable to agreed timelines and deliverables. </li>
<li>Capacity to effectively document historical vendor performance and leverage it for future pipeline planning. </li>
<li>Experience creating and implementing new processes based on role and company needs. </li>
<li>Experience reviewing, interpreting, and providing feedback on vendor contracts, including identifying risks, obligations, and compliance requirements. </li>
<li>Proven ability to manage the full lifecycle of vendor contracts, from negotiation through execution, renewal, and termination. </li>
</ul>

Certifications/Licenses, Education, and Experience:
<ul>
<li>Bachelor's degree in life sciences, healthcare, nursing, or related field (advanced degree preferred). </li>
<li>3–5 years of experience in clinical operations, vendor management, or clinical trial start-up. </li>
<li>Prior vendor-facing experience within clinical trials required. </li>
<li>Familiarity with vendor qualification systems, contracting workflows, and site activation processes. </li>
<li>Experience in SSU, Clinical Project Management, or Vendor Oversight strongly preferred. </li>
<li>Proficiency with CTMS, clinical portals, and project tracking tools. </li>
</ul>
How We Work Together
<ul>
<li>Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.</li>
<li>Travel: This is a remote position with less than 20% travel requirements. Occasional planned travel may be required as part of the role.</li>
<li>Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.</li>
</ul>
Benefits &amp; Perks
<ul>
<li>Paid Time Off (PTO) and Company Paid Holidays</li>
<li>100% Employer paid medical, dental, and vision insurance plan options</li>
<li>Health Savings Account and Flexible Spending Accounts</li>
<li>Bi-weekly HSA employer contribution</li>
<li>Company paid Short-Term Disability and Long-Term Disability</li>
<li>401(k) Retirement Plan, with Company Match </li>
</ul>
Diversity &amp; Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. 
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: <a href="mailto:TalentAcquisition@careaccess.com" target="_blank">TalentAcquisition@careaccess.com</a>

Clinical Vendor Activation Manager

<h3>Job Description</h3>
Job DescriptionCompany Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&nbsp;<a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on&nbsp;X,&nbsp;Facebook,&nbsp;Instagram,&nbsp;YouTube,&nbsp;LinkedIn&nbsp;and&nbsp;Tik Tok.
Job Description 
The CRA II advances AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position AbbVie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience.
Responsibilities:
<ul>
<li>Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.</li>
<li>Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li>
<li>Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li>
<li>Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li>
<li>Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li>
<li>Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.</li>
<li>May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li>
<li>Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.</li>
<li>Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li>
<li>Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li>
<li>Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.</li>
<li>Ensures audit and regulatory inspection readiness at assigned clinical site at all times.</li>
<li>Manages investigator payments as per executed contract obligations, as applicable.</li>
</ul>
Qualifications 
Minimum Qualifications:
<ul>
<li>Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. (CRA experience)</li>
<li>Familiar with risk-based monitoring approach, onsite and offsite monitoring.</li>
</ul>
Preferred Qualifications:
<ul>
<li>Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.</li>
<li>Knowledge of appropriate therapeutic area indications (oncology) is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li>
<li>Experience as a study coordinator&nbsp;</li>
</ul>
Other Required Skills:
<ul>
<li>Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li>
<li>Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li>
<li>Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li>
<li>Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li>
<li>Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li>
<li>Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li>
<li>Acts with integrity in accordance with AbbVie code of business conduct and leadership values.</li>
<li>Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&nbsp;local law:&nbsp;​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company&nbsp;believes in&nbsp;good faith it will pay for this role at the time&nbsp;of this posting based on the job grade for this position.&nbsp;Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and&nbsp;we&nbsp;may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the&nbsp;future. ​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&nbsp;medical/dental/vision&nbsp;insurance and 401(k) to eligible&nbsp;employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive&nbsp;programs.&nbsp;​
</li>
<li>
This job is eligible to participate in our long-term incentive&nbsp;programs​
</li>
</ul>
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and&nbsp;determinable.&nbsp;The amount and availability of any bonus,&nbsp;commission, incentive, benefits, or any other form of&nbsp;compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and&nbsp;absolute&nbsp;discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with&nbsp;applicable law.&nbsp;​
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.&nbsp;
US &amp; Puerto Rico only - to learn more, visit&nbsp;<a href="https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html" target="_blank">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.ht…</a>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
<a href="https://www.abbvie.com/join-us/reasonable-accommodations.html" target="_blank">https://www.abbvie.com/join-us/reasonable-accommodations.html</a>

Clinical Research Associate ll - Oncology (Remote - Philadelphia)

<h3>Job Description</h3>
Job DescriptionSalary: $62,000 - $77,000 
We are looking for an experienced Clinical Operations Manager I to join our team! 
 
Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!

This role is ideal for an individual who can motivate teams to do great work collaboratively in order to produce the best quality outcomes possible.

In this position you will:

<ul>
<li>Manage site identification and evaluation.</li>
<li>Develop or review essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals.</li>
<li>Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines and to facilitate approval of investigational product release. </li>
<li>Prepare central IRB submissions and resolve IRB issues.</li>
<li>Manage site enrollment and study subject tracking and payments.</li>
<li>Assist with the monitoring of project deliverables and project timelines.</li>
<li>Develop and distribute project documents (e.g. safety reports, lab reports, deviations reports, monitoring reports, follow-up letters, meeting minutes, newsletters, and regulatory documents)</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Provide investigational product or device tracking and disposition as required by project.</li>
<li>Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services. </li>
<li>Track and approve vendor payments.</li>
<li>Manage multidisciplinary project team members in relation to their role on assigned projects. Proactively identify issues and discuss resolutions with applicable department heads, project team, CPC executives and/or the sponsor. Track implementation of resolution through to completion and efficacy checks.</li>
<li>Ensure that the overall quality of project services and deliverables is maintained.</li>
<li>Provide status reports on all projects.</li>
<li>Participate in both onsite and offsite investigator meetings and training sessions.</li>
<li>Escalate budget, proposals and change orders discussions to Business Development.</li>
<li>Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Routinely advise management regarding the overall project status.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. </li>
<li>Schedule project team meetings and prepare meeting agendas and minutes as needed.</li>
<li>Perform other non-project related general administrative tasks such as filing, copying, faxing and shipping for assigned projects. </li>
<li>Cross-train within the project team, as needed. </li>
<li>Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li>Provide timely feedback on the progress of project assignments; help assess project issues and propose resolutions to the CPC project lead.</li>
<li>Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li>Oversee SAE process and assure execution of safety plans.</li>
<li>Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. </li>
<li>Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li>Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li>Manage the acquisition and supply of project specific materials to study sites.</li>
<li>Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li>Manage and conduct Endpoint and Specialty Services CPC Core Lab activities. </li>
</ul>

Heres what you will need to bring to the table:

<ul>
<li>Nursing degree or BA/BS in a scientific field (or equivalent knowledge/experience)</li>
<li>3 years of experience in a clinical research setting (required) or 1 year of experience as a Research Assistant (required)</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Experience with clinical site startup preferred.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li>Excellent communication and organizational skills. </li>
<li>Great attention to detail. </li>
<li>Ability to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel up to 25%.</li>
</ul>

Note:Viable applicants will be required to pass a background and education verification check.
 
Targeted Compensation: $62k - $77k annually
 
Deadline to Apply: August 1, 2025
 
About CPC:
 
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>

CPC offers:
 
<ul>
<li> Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li> Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li> 11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li> Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li> Flexible and remote work schedules</li>
</ul>

An Equal Opportunity Employer
 
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
 remote work

Clinical Operations Manager I

<h3>Job Description</h3>
Job DescriptionCompany Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&nbsp;<a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on&nbsp;X,&nbsp;Facebook,&nbsp;Instagram,&nbsp;YouTube,&nbsp;LinkedIn&nbsp;and&nbsp;Tik Tok.
Job Description 
The CRA II advances AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position AbbVie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience.
Responsibilities:
<ul>
<li>Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.</li>
<li>Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li>
<li>Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li>
<li>Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li>
<li>Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li>
<li>Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.</li>
<li>May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li>
<li>Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.</li>
<li>Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li>
<li>Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li>
<li>Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.</li>
<li>Ensures audit and regulatory inspection readiness at assigned clinical site at all times.</li>
<li>Manages investigator payments as per executed contract obligations, as applicable.</li>
</ul>
Qualifications 
Minimum Qualifications:
<ul>
<li>Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. (CRA experience)</li>
<li>Familiar with risk-based monitoring approach, onsite and offsite monitoring.</li>
</ul>
Preferred Qualifications:
<ul>
<li>Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.</li>
<li>Knowledge of appropriate therapeutic area indications (oncology) is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li>
<li>Experience as a study coordinator&nbsp;</li>
</ul>
Other Required Skills:
<ul>
<li>Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li>
<li>Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li>
<li>Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li>
<li>Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li>
<li>Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li>
<li>Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li>
<li>Acts with integrity in accordance with AbbVie code of business conduct and leadership values.</li>
<li>Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&nbsp;local law:&nbsp;​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company&nbsp;believes in&nbsp;good faith it will pay for this role at the time&nbsp;of this posting based on the job grade for this position.&nbsp;Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and&nbsp;we&nbsp;may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the&nbsp;future. ​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&nbsp;medical/dental/vision&nbsp;insurance and 401(k) to eligible&nbsp;employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive&nbsp;programs.&nbsp;​
</li>
<li>
This job is eligible to participate in our long-term incentive&nbsp;programs​
</li>
</ul>
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and&nbsp;determinable.&nbsp;The amount and availability of any bonus,&nbsp;commission, incentive, benefits, or any other form of&nbsp;compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and&nbsp;absolute&nbsp;discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with&nbsp;applicable law.&nbsp;
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.&nbsp;
US &amp; Puerto Rico only - to learn more, visit&nbsp;<a href="https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html" target="_blank">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.ht…</a>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
<a href="https://www.abbvie.com/join-us/reasonable-accommodations.html" target="_blank">https://www.abbvie.com/join-us/reasonable-accommodations.html</a>

297 Remote Clinical Trial Manager Jobs