Non-Clinical - Administrative - Clinical Research Coordinator

Senior Clinical Research Coordinator

Duration: 12 weeks, possible extension. This is a site based Senior Clinical Research Coordinator position. Candidates whose recent experience is primarily as a Clinical Research Associate (CRA), Site Monitor, or Sponsor/CRO Monitor are not a fit for this role. Candidates must have:

• 3+ years of Clinical Research Coordinator experience.
• 1+ year as a Senior CRC, Lead CRC, or in a leadership role.
• Strong knowledge of GCP, FDA regulations, IRB, and regulatory submissions.
• Experience managing multiple clinical trials from startup through closeout.
• Experience mentoring or training research staff.
• Academic medical center experience preferred.
• Stable employment history with demonstrated long term commitment.

Likely Declined - Primarily CRA or monitor experience without recent site based CRC experience. Multiple employment gaps and/or frequent short term positions. Candidates who prefer patient facing work over administrative and regulatory responsibilities. No leadership, mentoring, or supervisory experience.

Position Summary:

The Senior Clinical Research Coordinator is responsible for overseeing the day-to-day conduct of clinical research studies while ensuring compliance with sponsor, institutional, and regulatory requirements. This role provides leadership, mentorship, and operational oversight to research staff and supports the successful execution of a diverse portfolio of clinical trials.

Required Qualifications:

• Minimum of 3 years of clinical research coordination experience.
• At least 1 year of experience serving in a Senior Clinical Research Coordinator or equivalent leadership role.
• Advanced knowledge of:
  Good Clinical Practice (GCP) guidelines, FDA regulations, clinical research regulatory requirements.
• Experience mentoring, training, and supervising research staff and new team members.
• Knowledge of regulatory submission processes and workflows.

Key Responsibilities:

• Study Oversight & Operations:
• Provide oversight of daily research activities and study conduct across multiple clinical trials.
• Ensure all study procedures are conducted in compliance with sponsor, institutional, federal, and regulatory requirements.
• Support study start-up, maintenance, and close-out activities.
• Monitor study progress and proactively identify and resolve operational issues.
• Team Leadership & Mentorship:
• Mentor, train, and supervise research staff and new team members.
• Provide guidance on study procedures, policies, and best practices.
• Foster a collaborative and compliant research environment.
• Process Improvement:
• Develop, implement, and maintain Standard Operating Procedures (SOPs), workflows, and study manuals.
• Identify opportunities to improve operational efficiency and research quality.

Preferred Qualifications:

• Experience supporting a broad range of clinical research studies, including:
  Phase I–IV clinical trials, industry-sponsored studies, investigator-initiated studies, NIH-sponsored research, interventional and observational studies, non-profit and for-profit sponsored research.
• Experience working within an academic medical center environment.
• Familiarity with industry-sponsored clinical trials and sponsor interactions.

Additional Information:

• Budget management experience is not required.
• NIH and multicenter trial experience are preferred but not required.
• Candidates with experience in academic medical centers and exposure to diverse clinical trial portfolios are strongly encouraged to apply.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.