University of Rochester Manager, Clinical Research Coordinator - CHeT - 216651 in Rochester, New York
Manager, Clinical Research Coordinator - CHeT
School of Medicine & Dentistry
Full Time 40 hours Grade 055 Neuro-Ctr Health & Tech/CTCC
8 AM-5 PM; OCC WKENDS
The responsibility of the Clinical Project Coordinator, Senior is 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. Serves as the liaison to the Principal Investigator, study leadership and/or sponsor.
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. Engages with Finance for budget development and budget management.
Oversees entire study team, internal and external, including 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.
Oversees and 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. Directs the development, printing, and distribution of case report forms.
Oversees study team interactions with study sites relating to protocol clarifications.
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. Develops, as needed, Standard Operating Procedures (SOPs).
Receives from sites and appropriately reports notices of serious adverse experiences, drug adjustments, drug disclosures, and study terminations, etc. to study leadership and/or sponsors.
Serves as ex-officio member of various clinical trial Steering Committees and study group Executive Committees. Drafts and 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. At least 5 years of experience with clinical trials; extensive knowledge of protocol planning, implementation, coordination, evaluation, and reporting of clinical trials.
Strong attention to detail; project management; oral and writing skills; and interpersonal skills.
Previous management experience preferred.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled