Senior Clinical Research Coordinator

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.