Human Subject Res Coord II

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400626 Psychiatry M&D Research

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108

Compensation Range:

$51,810.00 - $72,534.00

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:

Coordinates human subject research activities, which may include multiple site human subject studies. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. Develops, implements and evaluates recruitment strategies, information, data systems and study management systems. Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents.

This position is a full-time position, with specific responsibilities (described below) divided between related studies pertaining to suicide prevention, sleep, and military readiness research. The Coordinator/Project Director will be responsible for implementation and oversight of the study protocols for clinical trials in the URMC Psychiatry Department and entails coordinating, directly conducting, and supervising all stages of human subjects research from recruitment to follow-up, interacting with research participants, and liaising with leadership and clinicians at referral sites. Coordinates human subject research activities which may include multiple site human subject studies. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. May supervise others.

RESPONSIBILITIES:

Project Management:

Oversees, coordinates and conducts human subject research activities for single or multiple sites. Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subject studies. Responsible for supporting the contacts and relationships between and among Principal Investigator, research staff, study sites, sponsoring and regulatory agencies.

Participant recruitment, enrollment and retention: Develops, implements and evaluates recruitment strategies, materials, information and data systems, as well as study management systems. Recruits and enrolls participants.

Follows up with study participants regarding assessments and document communications, including protocol deviations.

Data Management:

Reviews study progress and designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression. Under the direction of study statisticians helps develop, implement and monitor systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data.

Regulatory:

Coordinates and monitors study processes and study data for institutional review board (IRB) submissions and reporting, and for compliance with all institutional and funding agency requirements. Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.

Supervisory Duties:

Trains interns, research assistants and other staff about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Directs the activities of subord