Manager, Clinical Research

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 112

Compensation Range:

$70,197.00 - $105,295.00

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:

GENERAL PURPOSE:
Dr. Sheftall’s lab in the Dept. of Psychiatry, URMC, is dedicated to understanding the risk factors associated with youth suicidal behaviors. This position directly conducts and supervises human subjects research from recruitment to follow-up, interacting with research participants, and the supervision of post-bac Human Subject Research Coordinators and undergraduate students interested in paid positions with the Sheftall lab at the URMC Department of Psychiatry. May provide training to new staff members and student employees on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. Will be both enrolling patients and participating in community outreach. This position directly provides high level support, oversight, training, and coordination for all lab activities.

ESSENTIAL FUNCTIONS

• Participant recruitment, enrollment, and retention: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants. Follows up with study participants regarding assessments and document communications, including protocol deviations
• Supervisory duties: Trains new research staff members and/or student employees on the activities associated with conducting human subject research specific to study protocols and in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Directs the activities of staff members to gather, compile and analyze study information. Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities, and personnel. Provides feedback to staff members for annual reviews and ensures all staff specific plans for improvement are implemented appropriately (as needed).
• Data Management:  Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, including data, documentation, and reporting deliverables. Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression. Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures and protocols. Ensures all staff members are collecting data from participating families appropriately using standard operating procedures. Ability to create summary data as needed for reporting to the funding agencies, will complete all data exports for funding agencies and ensure documentation is updated appropriately, and edits databases as needed to meet all necessary regulatory guidelines.
• Regulatory: Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and relevant to research studies and designs, implements and monitors resulting study changes. Performs study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines and ensures each study's integrity. Will maintain all internal and external IRBs for all studies, will complete continuing reviews for all IRB approved studies, will assist with URMC quality improvement audits and will be responsible for submitting all regulatory/sponsor reporting.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree required
• 4 years of experience required
• Or equivalent combination o