40 hours/week, 3 Month Assignment (With possibility of extension)
A leading medical institution is seeking a Clinical Research Coordinator to oversee the day-to-day conduct of clinical research studies while ensuring compliance with sponsor, institutional, and regulatory requirements. This role provides operational leadership, mentorship, and oversight of research activities across a diverse portfolio of clinical trials.
Clinical Research Coordinator Responsibilities:
Oversee daily operations of multiple clinical research studies, ensuring compliance with sponsor, institutional, FDA, GCP, and regulatory requirements throughout study start-up, maintenance, monitoring, and close-out activities.
Monitor study progress, identify and resolve operational issues, maintain regulatory documentation, and support regulatory submission processes and study compliance activities.
Mentor, train, supervise, and provide guidance to research coordinators and research staff on study procedures, policies, workflows, and clinical research best practices.
Develop, implement, and maintain SOPs, study manuals, workflows, and process improvement initiatives to enhance research quality, compliance, and operational efficiency.
Collaborate with investigators, sponsors, monitors, and research teams to support Phase I-IV, industry-sponsored, investigator-initiated, NIH-sponsored, interventional, observational, multicenter, and academic medical center research studies.
Clinical Research Coordinator Qualifications:
3+ years of Clinical Research Coordinator experience.
1+ year of experience in a Senior Clinical Research Coordinator, Lead CRC, or equivalent leadership role.
Advanced knowledge of Good Clinical Practice (GCP), FDA regulations, and clinical research regulatory requirements.
Experience mentoring, training, and supervising research staff.
Experience with regulatory submissions and compliance processes.
Experience with Phase I–IV clinical trials is preferred.
Experience with Interventional and observational studies is preferred.
NIH and multicenter trial experience are preferred.
Experience working within an academic medical center environment is preferred.
Experience in academic medical centers and exposure to diverse clinical trial portfolios are preferred.