Job Description
Job DescriptionSalary: $70,000-90,000
About Us
At Axsendo Clinical Research, we believe that successful clinical trials go beyond mere transactions. We are a partnership, deeply invested in the journey from discovery to delivery. With a singular focus on advancing life-changing medical therapies, every aspect of our work is centered around the people involved, the processes we refine, and most importantly, the patients we aim to benefit. Through this compassionate and dedicated approach, we strive to transform the landscape of medical treatment and access to advancements in healthcare.
Position Overview
We are seeking an experienced Lead Clinical Research Coordinator to oversee and manage clinical trials within our facility. The ideal candidate will have a minimum of 2 years of clinical research experience, possess strong leadership skills, and demonstrate a commitment to excellence in patient care and research integrity. This role requires on-site presence five days a week and the flexibility to travel between local offices as needed. Phlebotomy experience is required.
Key Responsibilities
Oversee the design, initiation, execution, and closeout of clinical studies, ensuring adherence to protocols and regulatory requirements.
Recruit, screen, and enroll study participants; obtain informed consent and maintain accurate and confidential records.
Collect, enter, and manage study data with precision, ensuring data integrity and compliance with study protocols.
Prepare and manage Institutional Review Board (IRB) submissions, including responding to stipulations from ancillary review committees for new studies and modifications.
Ensure all activities comply with applicable laws and guidelines.
Provide guidance and mentorship to junior coordinators and support staff, fostering a collaborative and efficient work environment.
Perform blood draws and manage specimen handling in accordance with study requirements and best practices.
Serve as the primary liaison between investigators, participants, sponsors, and regulatory agencies; effectively communicate study objectives and progress.
Monitor study activities to ensure compliance with all protocols and regulatory standards; address and resolve any issues that arise during the research process.
Qualifications
Bachelor's degree in a health-related field, such as Nursing, Biology, or a related discipline.
Minimum of 2 years of experience as a Clinical Research Coordinator.
CCRC or ACRP certification is preferred.
Skills
Proficiency in phlebotomy techniques and specimen handling.
Experience using online CTMS, CRIO preferred but not required
Strong organizational and time-management abilities.
Excellent verbal and written communication skills.
Proficiency in Microsoft Office Suite and clinical trial management software.
Ability to work independently and as part of a multidisciplinary team.
Detail-oriented with a commitment to accuracy and compliance.
Experience in Pulmonology, Podiatry and Cardiology preferred.
Other Requirements
Valid driver's license and reliable transportation for travel between local offices.
Flexibility to work occasional evenings or weekends as study protocols require.
Benefits
Competitive salary commensurate with experience.
Health insurance optional after 90 days.
Paid time off and holidays.