The Senior Coordinator, Clinical Studies is responsible for the day-to-day management and oversight of protocol compliance, patient care, and coordination of clinical trials. This role includes collaborating with the principal investigator to resolve issues, training and mentoring staff, assisting with SOP writing and implementation, conducting quality assurance reviews, and assisting with supervisory functions as needed.
Principal Responsibilities
Coordinate, evaluate, and monitor patient progress on studies, including adverse events and protocol responses.
Collaborate with multidisciplinary teams to achieve trial objectives.
Screen patients for protocol eligibility and obtain informed consent.
Ensure patients are scheduled for required tests and appointments.
Complete clinical content templates for new protocol submissions and amendments.
Maintain delegation of authority and study-specific training logs.
Ensure data and regulatory documents are audit-ready.
Prepare continuing reviews and annual reports.
Conduct quality assurance data reviews
Provide guidance to research support staff for protocol compliance.
Communicate with clinical staff to ensure patient safety and protocol compliance.
Prepare and participate in data review meetings.
Enter data and maintain management reports in databases.
Assist in developing an onboarding training manual.
Develop training plans for incoming staff.
Provide updates on institutional policies.
Implement mentoring plans for incoming staff.
Qualifications:
Education: Bachelor's degree in Health Sciences.
Preferred Education: Master's Level Degree or Ph.D. in Health Sciences.
Preferred Certification: Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP)
Experience: Five years of experience in research study or direct patient care. May substitute required education with additional experience. With preferred degree, three years of required experience