Research Coordinator - RN

Location: City of Rochester

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:400157 Anesthes & Periop Med Research

Work Shift:

UR - Day (United States of America)
Range:

UR URCC 214 HCompensation Range:$35.35 - $45.96
* 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  The Clinical Trials Research Nurse is a registered professional nurse responsible for coordinating and conducting clinical research studies involving human subjects in compliance with national regulations, Good Clinical Practice (GCP) guidelines, institutional policies, and sponsor protocols. This role supports Phase I–III clinical trials and ensures the safety, rights, and well-being of research participants while maintaining high standards of data integrity and regulatory compliance.  

The Clinical Trials Research Nurse works collaboratively with principal investigators, research coordinators, sponsors, and multidisciplinary healthcare teams to facilitate study implementation, subject recruitment, clinical procedures, monitoring, and ongoing participant care.
** Key Responsibilities
** Clinical Research Operations – 40%
* Direct participant care, protocol-required procedures, monitoring for adverse events, specimen collection, and clinical assessments.
* Maintain accurate and complete source documentation in accordance with GCP and federal regulations (FDA, NIH, OHRP)
* Perform quality assurance reviews to ensure consistency between source documents and case report forms (CRFs).Participant Recruitment & Enrollment – 20%
* Screening, informed consent, eligibility reviews, outreach, and participant education.

Regulatory Compliance & Documentation – 15%
* Source documentation, AE/SAE reporting, audit preparation, and regulatory submissions.

Study Coordination & Quality Improvement – 10%
* Team meetings, protocol adherence monitoring, workflow optimization, and performance improvement initiatives.

Administrative & Support Functions – 10%
* Data entry, filing, scheduling, inventory control, and study material management.

Training & Professional Development – 5%
* Sponsor training, GCP certification, and continuing education.
** Clinical Research Operations
*** Conduct protocol-specific clinical procedures including venipuncture, ECGs, nasal swabs, urine collection, specimen processing, and vital sign monitoring.
* Perform structured and unstructured interviews to assess subject eligibility, clinical status, and adverse reactions.
* Monitor research participants for local and systemic reactions and document adverse events (AEs) and serious adverse events (SAEs).
* Ensure timely reporting of AEs and SAEs to sponsors, Institutional Review Boards (IRBs), and regulatory authorities.
** Participant Recruitment & Enrollment
*** Identify potential subject pools through clinic settings, community outreach, and referral sources.
* Conduct screening and eligibility assessments via in-person and telephone evaluations.
* Obtain and document informed consent ensuring participant comprehension and voluntary participation.
* Provide ongoing education to participants and families regarding study requirements, risks, and benefits.
** Regulatory Compliance & Documentation
*** Monitor for protocol deviations and implement corrective actions as needed.
* Assist with audits and inspections by sponsors and regulatory authorities.
** Study…