University of Rochester Clinical Project Coordinator, Associate - 236421 in Rochester, New York
Clinical Project Coordinator, Associate Job ID 236421Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 053 Neuro-Ctr Health & Tech/CTCCSchedule
8 AM-5 PM; OCC WKENDSResponsibilities
The responsibility of the Clinical Project Coordinator, Associate is to direct and coordinate all aspects of multi-center international clinical research trials.
Under general guidance and with 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. (25%)
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. (15%)
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. (15%)
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. (15%)
Determines and conveys protocol clarifications to sites by phone, fax, email and memo. (10%)
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). (10%)
Receives from sites and appropriately reports notices of serious adverse experiences, drug adjustments, drug disclosures, and study terminations, etc. (5%)
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. (5%)
Additional projects and job duties as assigned.
Bachelor’s degree, with major course works in appropriate health, social science, or biological science field; or equivalent combination of education and experience.
3-5 years of relevant clinical trials experience.
Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials.
Clinical trials project management experience preferred. Travel required.
Strong oral and writing skills, interpersonal and organizational skills, and attention to detail.
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled