Human Subject Res Coord II
This position is a full-time position, with specific responsibilities (described below) divided between related studies pertaining to sleep 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.
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.
- 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.
- 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 subordinate staff and relevant others to gather, compile and analyze study information.
- Deliver manualized study intervention under the direction and supervision of licensed providers.
- Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas.
Manuscripts and Presentations:
- Assists in the creation and submission of study findings to internal and external stakeholders, scientific communities and others as reports, abstracts, poster presentations, oral presentations and manuscripts.
Bachelor’s degree required
3 years of experience required
or equivalent combination of education and experience
Experience as Human Subject Research Coordinator 1 preferred
Word processing and data analysis software required
Professional Research Coordinator Certification (SoCRA or ACRP) preferred
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
Pay Range: $ 45,800 - $ 64,100 Annually
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.
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 053 Psychiatry M&D Research
Schedule: 8 AM-4:30 PM