The responsibility of the Clinical Project Coordinator, Senior to direct and coordinate all aspects of multi-center international clinical research trials, and to mentor, train, and/or supervise junior level project coordinators. Interacts with Principal Investigators and senior management.
Under general guidance and with considerable latitude for the exercise of independent judgment and initiative:
- Directs the planning, implementation and coordination of multi-center clinical trials sponsored by industry, government or private organizations.
- Plans internal meetings and provides professional direction within clinical trials coordination team. Oversees the planning and implementation of the Investigator’s/Coordinators’ meeting.Plans the study schedule timeline.Assists in budget development.
- Serves as liaison to study sponsors, clinical trial sites (average 20 per given trial), pharmacy department, clinical and research laboratories, contract research organizations, study principal investigators, study medical monitors, biostatistics department, data management unit, and administration/fiscal unit.
- Drafts the study protocol, synopsis and schedule of activities; drafts the study operations manual; designs templates for source documentation use at clinical trial sites; knowledge of drug packaging designs.Supervises the development, printing, and distribution of case report forms.
- Determines and conveys protocol clarifications to sites by phone, fax, email and memo.
- Oversees the development, collection and storage of regulatory documents required in clinical trial, e.g., FDA 1572, IRB approval, etc. Drafts requests and reports to regulatory agencies, e.g., IND application, annual IND update to FDA, etc.Has extensive working knowledge of Good Clinical Practices (GCP) guidelines applicable to study implementation and data management.Assists in developing Standard Operating Procedures (SOPs).
- Receives from sites and appropriately reports notices of serious adverse experiences, drug adjustments, drug disclosures, and study terminations, etc.
- Serves as ex-officio member of various clinical trial Steering Committees and study group Executive Committees.Reviews abstracts and manuscripts.Researches the literature.Attends and presents at professional meetings.
Bachelor’s degree, with major course works in appropriate health, social science, or biological science field; or equivalent combination of education and experience. Advanced degree highly preferred. 5 or more years’ experience with industry sponsored clinical trials; extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials. Strong oral and writing skills required.