<h3>Job Description</h3>
Job Description
About MMS
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.
Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.&nbsp;For more information, visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn.
We are looking for a motivated leader to join our Regulatory and Medical Writing Team!
Responsibilities:
<ul>
<li>Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.&nbsp;</li>
<li>Considers impact intra- and extra- depart, and responds accordingly (training, initiatives, tools, templates, etc.).</li>
<li>Proficient with QC, MW tools, training, and processes; provides mentorship to others, SME; connects different areas to create efficiencies.</li>
<li>Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Directs and controls the activities of a broad functional area through several department managers within the company. Oversees planning, staffing, and recommending and implementing changes to methods.&nbsp;</li>
<li>Experienced in understanding impact of updates in related deliverables; mentors others; advises on how initiatives and training in one area can impact other areas; mentorship across managers and departments.</li>
<li>Competent with managing client meetings and CRMs; provides mentorship to others; advises on how initiatives and training in one area can impact other areas; mentorship across managers.</li>
<li>Proficient with managing a project from start to finish; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers.</li>
<li>Proficient with identifying and mitigating project risk, including assessing client gaps; provides mentorship to others; considers impact to dept and business need; considerations across clients and dept; mentorship across managers and departments.</li>
<li>Adept at handling client feedback with appropriate follow-up or resolution; provides mentorship to others; considers impact to department and business need; considerations across clients and department mentorship across managers.</li>
<li>Provides strategic input in Resource Management (project resourcing and utilization)&nbsp;as it related to potential areas of growth; training of existing colleagues, recruiting needs and changes to the organizational structure.&nbsp;</li>
<li>Functions as a Business Lead which includes being client facing, promoting the regulatory and medical writing service line, stays in close collaboration with the commercial team on proposals, the business development team on capabilities and bid defenses, with other Business Leads cross-functionally, and the marketing team for various initiatives.&nbsp;</li>
</ul>
Requirements:
<ul>
<li>College graduate in Scientific, Medical, or Clinical discipline or related field, or related experience, Masters or PhD preferred.</li>
<li>Minimum of 10 years’ experience in Regulatory or Medical Writing, or similar field required.</li>
<li>Prior direct line management experience required.&nbsp;</li>
<li>Ability to anticipate and effectively resolve potential problems with client demands.</li>
<li>Demonstrates managerial skill and experience.</li>
<li>Proficiency with MS Office applications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Hands-on experience with clinical trial and pharmaceutical development preferred.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>Good organizational and communication skills.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li>
<li>Understanding of CROs and scientific and&nbsp;clinical data/ terminology, and&nbsp;the drug development process.&nbsp;&nbsp;&nbsp;</li>
</ul>
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Senior Manager, Regulatory and Medical Writing - Remote

<h3>Job Description</h3>
Job Description
POSITION SUMMARY:
The Clinical Research Associate helps design and execute clinical research studies. Work closely with Natera's clinical trials, medical education, and scientific communications teams to accomplish this end.
PRIMARY RESPONSIBILITIES:
<ul>
<li>Coordinate all aspects of a clinical study</li>
<li>Prepare and develop project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, IRB study protocols and amendments, and clinical summaries, as required</li>
<li>Assist with managing study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites</li>
<li>Track and manage clinical trial samples, including workflow design, inventory, and troubleshooting within sample management systems</li>
<li>Track participant data using in-house and CRO databases, and ensure that CRF data queries are resolved</li>
<li>Monitor and track clinical trial progress, provide status update reports, and manage project timelines</li>
<li>May train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues</li>
<li>Monitor studies following study monitoring plans</li>
<li>Occasionally educate and consent participants for research studies</li>
<li>Partner with other research and development groups at Natera to achieve deliverables</li>
<li>Coordinate review of data listings and preparation of interim/final clinical study reports</li>
<li>Provides operational and logistical support for one or more clinical trials/studies or initiative projects</li>
<li>Works on problems of moderate scope and complexity - Seeks guidance from manager and more senior peers as needed to determine the appropriate course of action</li>
<li>Builds solid working relationships within the Clinical Trial Operations organization</li>
<li>Contacts are internal to the company, but may interact with vendors/suppliers or clinical sites for routine requests</li>
<li>Demonstrates willingness to expand personal knowledge and commitment to own development</li>
<li>May suggest process improvements to manager to be considered as development opportunities</li>
<li>This role works with PHI on a regular basis both in paper and electronic form and utilizes various technologies to access PHI (paper and electronic) in order to perform the job. </li>
<li>Employee must complete training or provide training records relating to HIPAA/PHI privacy, Humans Subjects Protection, GCP, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire</li>
<li>Employee must complete training or provide training records relating to HIPAA/PHI privacy, Humans Subjects Protection, GCP, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire</li>
<li>Must maintain a current status on Natera training requirements</li>
<li>Performs other duties as assigned</li>
</ul>
QUALIFICATIONS:
<ul>
<li>BA/BS degree in life sciences, related field, or equivalent</li>
<li>Minimum of 2 years of experience in clinical research coordination and/or sample management</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES:
<ul>
<li>Familiarity with biospecimen management, sample processing, and biobanking best practices</li>
<li>Experience with clinical EDC systems</li>
<li>Familiarity with the organization and structure of the Trial Master File (TMF)</li>
<li>Competency in SOPs, ICH-GCP</li>
<li>Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint</li>
<li>Demonstrated ability to work independently</li>
<li>Outgoing and confident demeanor</li>
<li>Demonstrated analytical skills and ability to identify problems and propose solutions</li>
<li>Detail oriented, with solid organization and time management skills</li>
</ul>
PHYSICAL DEMANDS &amp; WORK ENVIRONMENT
· This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer is required. May stand for extended periods when facilitating meetings or walking in the facilities. 
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
Travel required for this position:
No _ or Yes _X_: If yes state anticipated percent for travel: &lt;10%
#LI-Remote
#LI-JW1
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years &amp; depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$81,600—$102,000 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit <a href="http://www.natera.com" target="_blank">www.natera.com</a>.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents. 
Link: <a href="https://www.natera.com/notice-of-data-collection-california-residents/" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a>
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Clinical Research Assoc

<h3>Job Description</h3>
Job DescriptionOur mission: to eliminate every barrier to mental health. 
At Spring Health, we're on a mission to revolutionize mental healthcare by removing every barrier that prevents people from getting the help they need, when they need it. Our clinically validated technology,Precision Mental Healthcare, empowers us to deliver the right care at the right time—whether it's therapy, coaching, medication, or beyond—tailored to each individual's needs.
We proudly partner with over 450 companies, from startups to multinational Fortune 500 corporations, as a leading provider of mental health service, providing care for 10 million people. Our clients include brands you use and know like Microsoft, Target, and Delta Airlines, all of whom trust us to deliver best-in-class outcomes for their employees globally. With our innovative platform, we've been able to generate a net positive ROI for employers and we are the only company in our category to earn external validation of net savings for customers.
We have raised capital from prominent investors including Generation Investment, Kinnevik, Tiger Global, Northzone, RRE Ventures, and many more. Thanks to their partnership and our latest Series E Funding, our current valuation has reached $3.3 billion. We're just getting started—join us on our journey to make mental healthcare accessible to everyone, everywhere.
We are looking for a senior research program manager to join our Health Economics and Outcomes Research team. The research program manager will own end-to-end management of our clinical study activities—from protocol initiation through close-out—ensuring timelines, quality, and compliance. This is a full-time position that is fully remote.
What You'll Be Doing
<ul>
<li>Develop and maintain detailed project plans, timelines, and budgets for clinical studies</li>
<li>Track and report study progress against key milestones, proactively identifying risks, process gaps, and implementing mitigation strategies.</li>
<li>Coordinate cross-functional timelines, and ensures on-time, within-budget execution of all clinical projects</li>
<li>Oversee protocol adherence and compliance activities, including IRB submissions, financial tracking, and management of study protocols in alignment with GCP and regulatory standards</li>
<li>Conducts daily reviews of quality and study-related records, initiates internal audits, identifies nonconformance's, and ensures corrective actions to maintain data integrity</li>
</ul>
What Success Looks Like in This Role
<ul>
<li>On-time Study Milestones: ≥ 90% of project milestones (study launch dates, targeted patient enrollment within planned timelines) met as scheduled.</li>
<li>Vendor Performance: ≥ 90% of vendor deliverables completed on time and within budget.</li>
<li>Retention Rates: ≥ 85% patient retention through primary endpoint.</li>
</ul>
What You'll Bring
<ul>
<li>Bachelor's or advanced degree in Life Sciences, Nursing, Pharmacy, or related field.</li>
<li>5-7 years of total experience, including 3+ years of hands-on experience in clinical operations or program management, preferably within mental health, biotech or pharma.</li>
<li>Solid knowledge of clinical trial lifecycle, GCP, FDA/EMA regulations.</li>
<li>Proven track record managing multiple, concurrent studies with cross-functional teams.</li>
<li>Exceptional organizational, communication, and stakeholder-management skills.</li>
</ul>
The target base salary range for this position is $136,500–$158,000, and is part of a competitive total rewards package including stock options and benefits. Individual pay may vary from the target range and is determined by a number of factors including experience, location, internal pay equity, and other relevant business considerations. We review all employee pay and compensation programs annually using Radford Global Compensation Databaseat minimum to ensure competitive and fair pay.
Benefits provided by Spring Health:
Note: We have even more benefits than listed here and below, your recruiter will provide more in-depth information as you continue in the interview process. Benefits are subject to individual plan requirements and eligibility criteria. 
<ul>
<li>Health, Dental, Vision benefits start on your first day at Spring. You and your dependents also receive access to One Medicalaccounts HSA and FSA plans are also available, with Spring contributing up to $1K for HSAs, depending on your plan type.</li>
<li>Employer sponsored 401(k) match of up to 2% for retirement planning</li>
<li>A yearly allotment of no cost visits to the Spring Health network of therapists, coaches, and medication management providers for you and your dependents.</li>
<li>We offer competitive paid time off policies including vacation, sick leave and company holidays.</li>
<li>At 6 months tenure with Spring, we offer parental leave of 18 weeks for birthing parents and 16 weeks for non-birthing parents.</li>
<li>Access to Noom, a weight management program—based in psychology, that's tailored to your unique needs and goals. </li>
<li>Access to fertility care support through Carrot, in addition to $4,000 reimbursement for related fertility expenses.</li>
<li>Access toWellhub, which connects employees to the best options for fitness, mindfulness, nutrition, and sleep in one subscription</li>
<li>Access to BrightHorizons, which provides sponsored child care, back-up care, and elder care</li>
<li>Up to $1,000 Professional Development Reimbursement a year.</li>
<li>$200 per year donation matching to support your favorite causes.</li>
</ul>
Not sure if you meet every requirement? Research shows that women and people from historically underrepresented communities often hesitate to apply for roles unless they meet every qualification compared to other similarly-qualified candidates. At Spring Health, we are committed to fostering a workplace where everyone feels valued, empowered, and supported to Thrive. If this role excites you, we encourage you to apply.
Ready to do the most impactful work of your life? Learn more about our values, what it's like to work here, and how hypergrowth meets impact at Spring Health:Our Values
Our privacy policy: <a href="https://springhealth.com/privacy-policy/" target="_blank">https://springhealth.com/privacy-policy/</a>
Spring Health is proud to be an equal opportunity employer. We do not discriminate in hiring or any employment decision based on race, color, religion, national origin, age, sex, marital status, ancestry, disability, genetic information, veteran status, gender identity or expression, sexual orientation, pregnancy, or other applicable legally protected characteristic. We also consider qualified applicants regardless of criminal histories, consistent with applicable legal requirements. Spring Health is also committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans. If you have a disability or special need that requires accommodation, please let us know.

Senior Research Program Manager

<h3>Job Description</h3>
Job DescriptionSalary: $50,000-$55,000 
Why DelRicht Research?
 
Would you love to be a part of the cutting edge of healthcare and science innovation? Do you want to be an influential part of a rapidly growing team? Are you looking for a position that has sustainable opportunity for professional growth? If the answer is yes, then DelRicht Research might be the right opportunity for you! We are a clinical research company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials. Our clinical trials provide new treatment options for our patients and, ultimately, our goal is to get new medications and medical devices FDA approved! We hold our team members to a high standard of excellence and are looking for energetic, positive, quick learners to be a part of our team.
 
DelRicht Research has been recognized as one of New Orleans Top Workplaces for 2023 and 2024! This is a testament to our unwavering commitment to creating an exceptional work environment that fosters growth, collaboration, and employee satisfaction.
 
NOTE: This is an onsite M-F position based at our Louisville location. No remote or hybrid seeking applicants please. Preference will be given to local candidates.
 
Who We Are
DelRicht is a clinical research company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials. Our clinical trials provide new treatment options for our patients and ultimately our goal is to get new medications and medical devices FDA approved! We hold our team members to a high standard of excellence and are looking for energetic, positive, quick learners to be a part of our team. Presently our network stretches across 33 sites throughout the United States in 18 states. 
 
Clinical Research Coordinators Main Objective:Overall, the Clinical Research Coordinator is responsible for providing quality, excellent patient care and a great experience for our patients in our clinical research studies and assisting the Site Manager in leading and developing the site and team.
 
<ul>
<li>Patients have a fun, positive and comfortable experience at our clinic</li>
<li>Patient visits are accurate and efficient</li>
<li>Patient recruitment and enrollment into clinical trials</li>
<li>Seeing to it that all clinical trial protocols are being adhered to 100% of the time</li>
<li>Maintain site audit readiness at all times</li>
<li>Assist Central Quality Assurance Team and Site Manager with Quality Assurance</li>
<li>Lead and main point of contact for Sponsors and CROs for all studies</li>
<li>Ensuring Sponsors and Clients have amazing customer service when they are onsite at our clinic and assuring we are always providing clear, constant communication with them when they are off site</li>
<li>Maintaining Physician Trust - You are seen as a go to, knowledgeable resource to our physicians including ensuring the physician is well informed of their schedule and updated on all current clinical trial patients and protocols</li>
</ul>
 
Skills needed to win:
 
<ul>
<li>Required: 2-3 years of professional work experience</li>
<li>Required: 2 years of experience in a patient-facing healthcare setting (preferred experience within Psychiatry, Emergency Medicine, or high volume Inpatient or Outpatient Clinical Environments) </li>
<li>Preferred: Healthcare certification such as Medical Assistant, Licensed Practical Nurse, or Phlebotomist </li>
<li>Preferred: B.S or B.A from any accredited university in any degree or transferrable experience </li>
<li>Prior clinical research experience is not required (but wonderful if you have it, of course!)</li>
</ul>
 
The right candidate will:
 
<ul>
<li>Be self motivated! Energetic! Positive!</li>
<li>Focus on providing exceptional patient care and creating memorable experiences</li>
<li>Make sure client satisfaction is a primary focus and that the client is able to achieve and exceed their goals</li>
<li>Believe in high quality and have a high standard of compliance to our study protocols</li>
<li>Be remarkably organized</li>
<li>Be skilled at problem solving</li>
<li>Manage multiple tasks and clinical trials efficiently</li>
<li>Accept ownership of tasks from inception through completion and assume responsibility for personal success</li>
<li>A great, coachable attitude and a willingness to learn</li>
<li>Enjoyment of a fast-paced working environment</li>
<li>Coffee drinkers preferred. Tea drinkers accepted.</li>
</ul>
 
DelRicht Researchs Core Values: Production, Humility, Consistency
 
Production:
<ul>
<li>We deliver on our promises</li>
<li>We have a bias towards action: we value independent problem solving</li>
<li>We proactively over deliver: we can act without being told what to do and we always have new ideas that will be heard and will improve the company</li>
</ul>
Humility:
<ul>
<li>We support each other relentlessly</li>
<li>We always have enthusiasm: we exhibit passion and excitement about our work which leads to everyone having a can do attitude</li>
<li>We embrace change: we are excited to always be growing and moving the organization forward which means change is the norm for us</li>
<li>Coachable: we all love to learn, we are willing to be taught and will adapt quickly</li>
</ul>
Consistency:
<ul>
<li>We always are able to execute: we get it right the first time and promote touch it once accuracy</li>
<li>We have persistence: we demonstrate the tenacity and willingness to go the distance to get something done</li>
<li>We are calm under pressure: we can maintain stable performance when under heavy pressure or stress</li>
</ul>
 
Team Perks &amp; Benefits at DelRicht Research:
<ul>
<li>Medical, Dental, Vision</li>
<li>Generous Paid Time Off that builds throughout your career with the company</li>
<li>No nights or weekends</li>
<li>401K (+ discretionary match/profit sharing)</li>
<li>Exceptional quarterly bonus plan that clearly outlines your bonus potential per quarter and giving the team the visibility and control to maximize earnings by hitting team goals</li>
<li>Voluntary travel to nationwide conferences to learn about new clinical studies (US based, all expenses paid - who doesn't like free travel?)</li>
</ul>
 
Job Type:Full-Time 40+ hrs
 
Visit our website linked below to learn about our company and current clinical trials, see patient testimonials, and check out our careers page!
 
Website: <a href="http://www.delrichtresearch.com" target="_blank">www.delrichtresearch.com</a>
Patient Testimonials: <a href="https://delrichtresearch.com/testimonials/" target="_blank">https://delrichtresearch.com/testimonials/</a>
 
We are an equal opportunity employer and consider all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Clinical Research Coordinator

<h3>Job Description</h3>
Job DescriptionSalary: $80,000 - $115,000 
Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA. Our mission is to bring innovation to clinicaltrial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.
 We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a white glove service approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients needs as they evolve. 
 
Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.
 
Position Overview:
This is an exciting opportunity to join a young and lively company in a fast-paced and dynamic environment. 
 
The Clinical Data Specialist (CDS) will be responsible for project assigned tasks under direction of the Lead Data Manager and/or Director of Clinical Data Management; Ensuring clinical data review activities are conducted in an effective efficient manner and in accordance with Standard Operating Procedures (SOPs), regulatory directives; and study specific plans.
 
Essential Duties &amp; Responsibilities:
<ul>
<li>The Clinical Data Specialist (CDS) will be responsible for clinical data review as assigned.</li>
<li>The review tasks performed by this role include both point-to-point clinical data checks and interpretive analysis such as reviewing datafor submission, highlighting errors, raising queries etc.</li>
<li>Ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to supportsubmissions, Data Monitoring Committee reviews and publications.</li>
<li>Provide support as required to address data related issues internally.</li>
<li>Attends Clinical Meetings and Study Meetings, as necessary.</li>
<li>Participate in User Acceptance Testing to ensure accuracy of CRFs, custom functions and edit checks, as applicable.</li>
<li>Performs data cleaning to identify data trends.</li>
<li>May Participate in data review meetings.</li>
<li>Review and query clinical trial data according to the Data Management Plan.</li>
<li>Perform External Data Reconciliations.</li>
<li>Review listing for data review based on the guidance provided by the sponsor and/or Director of Data Management.</li>
<li>Provide support to audit and inspection and management to address issues identified during data review.</li>
<li>Run patient and study level status and metric reports.</li>
<li>Perform SAE/AE reconciliations.</li>
<li>Other duties as assigned.</li>
</ul>
 
Experience &amp; Skills:
<ul>
<li>2 years or more experience in Clinical Data Review in either a CRO/or pharmaceutical or biotech industry or equivalent relevant experienceand or demonstrated competencies / Senior CDR Level: 4 years or more experience in Clinical Data Review in either a CRO/orpharmaceutical or biotech industry.</li>
<li>Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.</li>
<li>Able to handle a variety of clinical research tasks.</li>
<li>Excellent organizational and communication skills.</li>
<li>Professional use of the English language; both written and oral.</li>
<li>Experience in utilizing various clinical database management systems.</li>
<li>Ability to travel domestically and internationally with overnight stays.</li>
<li>Ability to work independently, manage time and create plans to achieve personnel goals.</li>
<li>Ability to work effectively with minimal direction; must be a self-motivated and self-directed individual who enjoys a challenging and dynamic work environment.</li>
<li>Team player willing to collaborate and share knowledge.</li>
<li>Highly organized.</li>
<li>Effective communication skills.</li>
<li>Excellent organization and prioritization skills.</li>
</ul>
 
Education:
Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees with relevant industry experience will be considered.
 
Compensation Range:
Clinical Data Reviewer:$80,000 - 100,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)
Senior Clinical Data Reviewer: $90,000 - 115,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)
 
COVID-19 Vaccination: To protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the client site requirements. Proof of vaccination may be required, in accordance with applicable laws.
 
Vanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to 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.
 remote work

Clinical Data Specialist

<h3>Job Description</h3>
Job DescriptionPOSITION SUMMARY:
A Clinical Trials Contract Specialist is responsible for the development, negotiation, and management of clinical trial agreements. This role ensures compliance with regulatory requirements, institutional policies, and sponsor expectations.
The Contract Specialist works closely with study teams, Legal, Accounts Payable, and clinical site personnel to support the logistical and administrative aspects of multiple clinical trials. The position operates with oversight from the Senior Manager, Budgets &amp; Contracts, and adheres to company policies, study protocols, SOPs, and applicable regulatory requirements.
PRIMARY RESPONSIBILITIES:
<ul>
<li>
Support cross-functional initiatives with a focus on customer experience and business operations.
</li>
<li>
Collaborate with Legal, study teams, vendors, and sites to address contract concerns and ensure alignment for execution.
</li>
<li>
Draft, review, and negotiate Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), including Clinical Study Agreements (CSAs), Statements of Work (SOWs), Investigator Sponsored Agreements (ISAs), amendments, and related documents.
</li>
<li>
Ensure all agreements comply with FDA regulations, institutional policies, and ethical standards.
</li>
<li>
Serve as the primary point of contact for contract-related inquiries from internal and external stakeholders.
</li>
<li>
Maintain accurate and up-to-date contract files, databases, and tracking systems.
</li>
<li>
Monitor contract milestones and deadlines to ensure timely completion and avoid delays.
</li>
<li>
Provide guidance to investigators and study teams on contract-related matters.
</li>
<li>
Identify and mitigate risks associated with clinical trial contracts.
</li>
<li>
Participate in continuous improvement initiatives related to contract processes.
</li>
<li>
Performs other duties and special projects as assigned.
</li>
</ul>
QUALIFICATIONS:
<ul>
<li>
Bachelor's degree required; scientific discipline preferred.
</li>
<li>
Minimum of 5 years of experience working on clinical studies in biopharma, diagnostics, or medical device fields.
</li>
<li>
At least 3 years of experience negotiating investigator site agreements.
</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES:
Technical:
<ul>
<li>
Familiarity with clinical Electronic Data Capture (EDC) systems.
</li>
<li>
Strong understanding of SOPs, ICH-GCP, and FDA regulations.
</li>
<li>
Proficiency in Google Workspace (gSuite), MS Word, Excel, and PowerPoint.
</li>
<li>
Experience with Salesforce, contract management, and enterprise systems preferred.
</li>
<li>
Strong analytical skills and ability to develop solutions to contractual issues.
</li>
</ul>
Behavioral:
<ul>
<li>
Excellent negotiation, communication, and interpersonal skills.
</li>
<li>
Ability to manage a high-volume workload and meet project-specific deadlines.
</li>
<li>
Flexibility and independence in managing contract negotiations.
</li>
<li>
Collaborative mindset to interact with internal and external stakeholders.
</li>
</ul>
Preferred:
<ul>
<li>
Experience with vendor management.
</li>
<li>
Experience with Investigator Sponsored Agreements (ISAs).
</li>
</ul>
PHYSICAL DEMANDS &amp; WORK ENVIRONMENT:
Duties are typically performed remotely. This position requires the use of a computer keyboard, communication via phone, and reading printed/digital materials. Duties may occasionally require work outside normal business hours, including evenings and weekends.
Travel Requirement:
☒ No
#LI-Remote
#LI-JW1
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years &amp; depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$114,700—$143,400 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit <a href="http://www.natera.com" target="_blank">www.natera.com</a>.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents. 
Link: <a href="https://www.natera.com/notice-of-data-collection-california-residents/" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a>
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Clinical Trials Contract Specialist

<h3>Job Description</h3>
Job Description
Status: Full-time, Exempt
Reports to: Clinical Trials Manager
Role Summary
T45 Labs is seeking a Senior Clinical Research Associate (CRA) to independently manage site monitoring and clinical operations activities across a range of medtech clinical trials. This individual will be responsible for overseeing site performance, ensuring regulatory compliance, and supporting cross-functional trial execution. The ideal candidate will have 5+ years of experience in clinical research, including direct monitoring of investigational sites, and will bring a deep understanding of FDA, ICH-GCP, and ISO 14155 standards, ideally with a background in medical device trials.
Responsibilities
Site Monitoring &amp; Oversight
<ul>
<li>Independently perform site qualification, initiation, monitoring, and close-out visits, ensuring compliance with the protocol, GCP, and applicable regulations.</li>
<li>Ensure source data verification (SDV), informed consent processes, and IP accountability are maintained at each site.</li>
<li>Serve as the main point of contact for investigative sites, providing guidance and support to ensure optimal site performance.</li>
<li>Proactively identify and address protocol deviations, data discrepancies, and site challenges.</li>
<li>Ensure all site documentation is current, complete, and audit-ready within the Trial Master File (TMF).</li>
</ul>
Clinical Operations Support
<ul>
<li>Contribute to the development and review of trial documents such as protocols, case report forms (CRFs), monitoring plans, and ICFs.</li>
<li>Draft and submit monitoring visit reports and follow-up communications in a timely and accurate manner.</li>
<li>Collaborate with Clinical Operations leadership to ensure project timelines, enrollment targets, and quality metrics are met.</li>
<li>Assist in preparation for regulatory audits and inspections.</li>
</ul>
Cross-Functional Collaboration
<ul>
<li>Work closely with Project Management, Regulatory, Data Management, and Quality teams to ensure smooth trial execution.</li>
<li>Contribute to investigator meetings, site training sessions, and internal clinical team discussions.</li>
<li>Provide mentoring or informal support to junior CRAs or Clinical Trial Associates.</li>
</ul>
Qualifications
<ul>
<li>Bachelor’s degree in Life Sciences, Nursing, or a related field (advanced degree or certification preferred).</li>
<li>5+ years of clinical research experience, including independent site monitoring responsibilities.</li>
<li>Strong knowledge of FDA, ICH-GCP, ISO 14155, and applicable clinical research regulations.</li>
<li>Demonstrated experience with medical device clinical trials preferred.</li>
<li>Proficient in CTMS, EDC, and eTMF systems; strong documentation and reporting skills.</li>
<li>Excellent interpersonal, organizational, and problem-solving skills.</li>
<li>Ability and willingness to travel up to 35%, including in-person site visits as required.</li>
</ul>
Location &amp; Compensation
This position is open to remote candidates; however, preference will be given to applicants located in the San Francisco Bay Area. Candidates based in the Bay Area are generally expected to work in our Santa Clara office at least one day per week to support in-person collaboration and team activities.
T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.
The anticipated salary range for this position is $122,000 - $166,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as experience, skills, and geographic location.
Third-Party Recruiter Notice
We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email <a href="mailto:careers@t45labs.com" target="_blank">careers@t45labs.com</a>.

Clinical Research Associate

<h3>Job Description</h3>
Job DescriptionIf you are an experienced Senior&nbsp;Clinical Quality Assurance Auditor&nbsp;(internally referred to as Senior&nbsp;Clinical Quality Assurance Manager)&nbsp;who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! Translational Research in Oncology (TRIO)&nbsp;is a global academic clinical research organization&nbsp;dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is seeking a Senior&nbsp;Clinical Quality Assurance Auditor&nbsp;(internally referred to as Senior&nbsp;Clinical Quality Assurance Manager)&nbsp;to join our Quality Assurance team. Reporting to the Senior Director of Quality Assurance, this position will be remote-based in the United States. 
Responsibilities:
<ol>
<li>Conduct Audits: Plan and execute comprehensive audits of clinical trials. This includes auditing clinical trial master files, internal processes, investigator sites, contract research organizations (CROs), and other relevant entities&nbsp;to assess compliance with relevant regulations, guidelines, and standard operating procedures (SOPs).&nbsp;</li>
<li>Host Audits/Inspections: Assist in hosting Sponsor audits and Regulatory Authority inspections. This includes providing support in coordinating the preparation and conduct of the audit/inspection, and in developing the responses (CAPA) to any findings,</li>
<li>Quality Assurance Documentation: Develop and maintain quality assurance documentation, including audit plans, audit reports, inspection readiness plans, and other relevant documents. Ensure accurate and timely documentation of audit findings, observations, and corrective actions taken.&nbsp;</li>
<li>Training and Education: Provide training and guidance to internal staff and external stakeholders on quality assurance practices, regulations, and industry standards related to clinical research. Foster a culture of quality and compliance through educational initiatives and ongoing support.&nbsp;</li>
<li>
Quality Management System:&nbsp;Provide support in developing and maintaining the Quality Management System of the Organization, including support in the creation and revision of written procedures, conducting trending and metrics analysis for the QA activities
</li>
<li>Process Improvement: Collaborate with cross-functional teams to identify areas for process improvement and develop strategies to enhance the efficiency and effectiveness of clinical quality systems. Implement best practices and drive continuous improvement initiatives.&nbsp;</li>
<li>Regulatory Compliance: Stay updated with current regulations, guidelines, and industry trends pertaining to clinical quality assurance. Interpret and communicate regulatory requirements to ensure compliance across clinical research activities.&nbsp;</li>
<li>Risk Assessment: Conduct risk assessments related to clinical quality assurance to identify potential vulnerabilities and areas of concern. Develop risk mitigation strategies and ensure appropriate controls are implemented.&nbsp;</li>
<li>Collaboration and Communication: Foster strong working relationships with internal stakeholders, including clinical operations, regulatory affairs, data management, and other departments. Collaborate effectively with external parties, such as auditors, regulatory authorities, and vendors, to facilitate audits, inspections, and regulatory submissions.&nbsp;</li>
</ol>
Requirements:
<ul>
<li>Bachelor's degree in a relevant scientific field (such as life sciences, pharmacy, or nursing). A higher degree (Master's or Ph.D.) is advantageous.&nbsp;</li>
<li>Minimum 5 experience in clinical quality assurance (8 preferred) , including conducting audits and inspections in the pharmaceutical, biotechnology, or clinical research organization (CRO) setting.&nbsp;</li>
<li>In-depth knowledge of applicable regulations and guidelines, such as Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and relevant regional requirements (e.g., FDA, EMA).&nbsp;</li>
<li>Strong understanding of clinical trial processes, including study design, protocol development, data management, and adverse event reporting.&nbsp;</li>
<li>Excellent analytical and problem-solving skills, with the ability to critically evaluate complex data, identify trends, and propose effective solutions.&nbsp;</li>
<li>Demonstrated leadership abilities, including the ability to mentor and guide junior team members, and effectively collaborate with cross-functional teams.&nbsp;</li>
<li>Excellent communication skills, both written and verbal, with the ability to effectively communicate complex concepts and audit findings to various stakeholders.&nbsp;</li>
<li>Attention to detail, with a strong commitment to accuracy and quality in all work performed.&nbsp;</li>
<li>Relevant certifications, such as Certified Quality Auditor (CQA), Certified Clinical Research Professional (CCRP), or similar, are highly desirable.&nbsp;</li>
<li>Knowledge of risk-based quality management principles and experience with risk assessment methodologies is a plus.&nbsp;</li>
<li>Fluent oral and written English is required,&nbsp;&nbsp;</li>
<li>Intermediate proficiency in Word, Excel, and PowerPoint, is required.</li>
<li>Ability to travel worldwide (Europe, North America, Asia and occasionally in other locations), on an as-needed basis.</li>
</ul>
What TRIO Can Offer You:&nbsp;
<ul>
<li>Annual compensation review with opportunities for professional growth</li>
<li>3 weeks of vacation plus paid December Holiday Closure</li>
<li>10 days paid personal/sick time</li>
<li>1 paid volunteer day / year</li>
<li>A top tier, comprehensive Health / Medical plan for you and your family – Monthly premiums paid for by TRIO</li>
<li>Up to 5% matching 401(k) Program</li>
<li>Flexible working hours to promote work-life balance</li>
<li>Monthly Internet&nbsp;Allowance to support working from home</li>
<li>Remote work arrangements anywhere across the USA and receive a one-time home office allowance</li>
<li>Mobile Phone Stipend available for qualifying positions</li>
<li>Out-of-country Work: Employees can request to work internationally for a short period of time each year</li>
<li>Employee Family Assistance Program to support you and your family during difficult times</li>
<li>Employee Recognition Program to reward long-term employees</li>
<li>Employee Referral Bonus Program</li>
</ul>
 Pay Range: $80,000.00 to $110,000.00&nbsp;- Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data. &nbsp;
Teamwork · Passion · Integrity · Innovation 
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