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University of Rochester Mgr Clin Res Coord (S) - Hybrid Work Opportunity - 231020 in Rochester, New York

Mgr Clin Res Coord (S) - Hybrid Work Opportunity Job ID 231020

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 055 CCRC

Schedule

8 AM-4:30 PM

Responsibilities

Hybrid Work Opportunity

General Purpose:

Plans, directs and coordinates study phases of FDA, NIH, and Investigator-Initiated clinical trials for multi-center and single center research with extensive responsibility for staff supervision, oversight of study startup, maintenance and closeout activities, SOPs, training, and regulatory compliance with considerable latitude for the exercise of independent judgement and initiative.

Supervision:

Receives general direction and administrative supervision from the Program Manager.

Specific Responsibilities:

25% Plans and implements study phases for research projects to ensure objectives outlined in the project will be accomplished in accordance with prescribed priorities, time limitations, and funding conditions through initiation and oversight of team meetings and activities.

25% Supervises and ensures study operations comply with government reporting and funding regulatory requirements including preparation of study activities, protocol, consents, SOPs, INDs and IDEs.

15% Coordinates administrative efforts and trains investigators and coordinators at participating centers. Supervises on-site monitoring of participating centers, if applicable.

15% Plans and implements a comprehensive data management and information systems in conjunction with the IT/computer programming staff. Develops eCRFs and assists with data collection, data reports, and analysis.

10% Initiates and participates in meetings, evaluates enrolling centers, and confers with sponsor, regulatory agencies, IRBs and University administration.

5% Hires, trains, supervises, and evaluates CCRC staff with regard to performance and study responsibilities.

5% Maintains a good working knowledge of the cardiovascular research literature and regulatory compliance issues both in general and as it relates to the specific tasks assigned through attendance at national meetings and interactions with study sponsors.

Requirements:

Bachelor’s degree and 5 years of experience in clinical research, preferably management experience; or an equivalent combination of education and experience. 5-7 years of experience in industry sponsored clinical research requiring FDA/ISO compliance highly preferred. Prefer clinical background in nursing or other clinical specialty.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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