Human Subject Res Coord II

Rochester, NY


Reports to Senior Human Subject Research Coord. III (May supervise others)

With minimum direction and latitude for independent judgement, the Human Subject Research Coordinator II (HSRC II) coordinates human subject research activities within the Division of Gastroenterology and Hepatology. The HSRC II, keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies, as well as designs, implements and monitors resulting study changes. HSRC II is expected to keep current with and provide training on federal, state, sponsor and/or institutional regulations, policies and procedures related to human subject research as well as supervise others. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines.


Assigned Research Protocols/Studies:

  • Oversees and coordinates human subject research activities for single or multiple trials

  • Participates in the implementation of all protocols, including inclusion and exclusion criteria, informed consent procedures, conducts all study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting

  • Performs vital signs, EKGs, biometric measurements, and phlebotomy during subject visits

  • Performs laboratory processing and shipping of subject biological samples

  • Reviews and documents the dispensing and returning of study materials (such as study drugs and devices)

  • Conducts human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet protocol eligibility criteria. May participate in developing recruitment strategies

Quality and Compliance

  • Represents sites, providers, study team, patients, study participants and the University with regard to the coordination of human subject studies

  • Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures (SOPs) and guidelines

  • Acts as a liaison with Sponsor’s monitor to provide data clarifications and review study protocols and ensures compliance with all applicable regulatory and institutional requirements and standards

  • Ensures the integrity and security of all study data at all times

  • Responsible for maintaining regulatory IRB submissions and reporting requirements for all studies

Training and Oversight:

  • Trains Level I research coordinators and other staff about activities associated with conducting human subject research

  • Trains study staff on the specific updates to study protocols in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.

  • Monitors for IRB compliance with all institutional requirements for adequate system controls

Other Duties – as assigned

  • Assist as needed with projects and programs that support the mission of the division, research department and members of the research team

  • May include travel for study specific training


  • Bachelor’s degree required

  • 3 years of human subject research coordination; or an equivalent combination of education and experience required

  • Experience and proficiency in working with Microsoft Office applications (Word, Excel, PowerPoint, etc.) preferred

  • Electronic Medical Record Experience

  • Professional Research Coordinator Certification 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

Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 53 Medicine M&D-Gastroentrol Div
Schedule: 8 AM-4:30 PM