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Job Location (Full Address):

Select a Shipping Address, Rochester, New York, United States of America, 14627

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400980 Neuro-Ctr Health & Tech/Admin

Grade:

UR URG 112

Compensation Range:

$68,400.00 - $102,600.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

.

Manages the activities associated with establishing a network of Principle Investigators (PIs) from community based physicians. Manages Clinical Research Coordinators and Associates, including ensuring proper training in study protocols and Good Clinical Practices (GCPs).Schedule 8 AM-5 PM; OCC WKNDS Responsibilities The Center for Health + Technology (CHeT) is a research organization within the University of Rochester that aims to enable anyone anywhere to receive care and participate in research. To do so, CHeT employs over 80 talented and diverse individuals to conduct unprecedented studies to evaluate new treatments and measures of disease. Over the past 30 years, CHeT has conducted over 100 studies and enrolled over 40,000 participants, leading to seven FDA-approved drugs for Parkinson's disease, Huntington disease, and other neurological conditions. GENERAL PURPOSE: The responsibility of the Sr Clinical Project Manager 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. SPECIFIC RESPONSIBILITIES: 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. (20%) - 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. (15%) - Oversees, trains, and mentors 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. (15%) - 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. (15%) - Oversees study team interactions with study sites relating to protocol clarifications. (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. Develops, as needed, Standard Operating Procedures (SOPs). (10%) - 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. (5%) - 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. Participates and presents at professional meetings. (5%) - Other projects and job duties as assigned. 5% REQUIREMENTS: - 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; presentation, interpersonal, and communication skills, including written communication. - Previous management experience preferred. To apply, send cover letter and resume to Renee.Wilson@chet.rochester.edu

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