Certified Clinical Research Coordinator - PRN
We are seeking a knowledgeable and motivated Certified Clinical Research Coordinator (CCRC) to join our team on a PRN basis at our Volusia-Flagler Vascular Center. The ideal candidate will have a strong background in clinical research, excellent organizational skills, and the ability to work effectively in a dynamic environment. You will be responsible for coordinating clinical trials, ensuring compliance with regulatory requirements, and maintaining the integrity of study data.
Key Responsibilities:
- Coordinate all operational aspects of assigned clinical trials following Good Clinical Practice (GCP), internal policies, and regulatory requirements.
- Act as the primary point of contact between study sponsors, investigators, and study participants.
- Obtain informed consent from study participants and ensure they understand the study's purpose and procedures.
- Schedule and conduct study visits, including participant assessments, laboratory tests, and data collection.
- Monitor participant safety and report any adverse events as per protocol guidelines.
- Maintain accurate, detailed, and timely records of study activities in compliance with regulatory and institutional requirements.
- Collaborate with principal investigators and other team members to develop study protocols, case report forms, and databases.
- Manage study supplies, including investigational products, and ensure proper storage and accountability.
- Assist in the preparation and submission of regulatory documents to Institutional Review Boards (IRBs) and regulatory agencies.
- Conduct training sessions for staff, study personnel, and participants on study protocols and procedures.
- Participate in study meetings, data review, and problem-solving activities.
- Stay updated on current industry trends, guidelines, and regulations related to clinical research.
Qualifications:
- Certified Clinical Research Coordinator (CCRC) certification required.
- Bachelor’s degree in a health-related field (nursing, life sciences, or equivalent) preferred.
- A minimum of 3 Years of experience in clinical research coordination.
- Knowledge of GCP, FDA regulations, and other applicable guidelines.
- Strong organizational skills with attention to detail in managing multiple tasks simultaneously.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a multidisciplinary team.
- Proficiency in electronic data capture systems and Microsoft Office Suite.
- Strong interpersonal skills and the ability to build rapport with study participants and team members.
Work Environment:
This position may require flexibility in work hours based on clinical trial needs, including evening or weekend hours. The role will involve interaction with clinical staff, study participants, and sponsors.
American Vascular Associates is an equal opportunity employer committed to diversity and inclusion in the workplace. We encourage all qualified applicants to apply.