Research Coordinator - RN

apartment University of Rochester Medical Center location_onRochester, NY 14642, US

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:

Department:

400157 Anesthes & Periop Med Research

Work Shift:

UR - Day (United States of America)

Range:

UR URCC 214 H

Compensation 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 Coordination & Quality Improvement

Participate in study team and sponsor meetings throughout the trial lifecycle.
Collaborate with investigators and research staff to improve site performance and data quality.
Contribute to process improvement initiatives to enhance participant safety and study efficiency.

Administrative & Support Functions

Track participant visits and prepare compensation requests.
Manage inventory of study supplies and maintain organized exam and research areas.
Support data entry, filing, correspondence, and development of study-related documentation.
Assist with compiling study metrics and reports as required.

National Standards & Compliance

This position adheres to national and international clinical research regulations including: FDA Clinical Trial Regulations
Office for Human Research Protections (OHRP) guidelines
HIPAA privacy standards
Institutional Review Board (IRB) policies and procedures

Qualifications

Associate Degree in Nursing (ADN) required
Bachelor of Science in Nursing (BSN) preferred
Active Registered Nurse (RN) license in the practicing state and/or compact license
Minimum of 1 year clinical nursing experience; clinical trials experience preferred or a combination of education and experience
Proficiency in phlebotomy and adult patient care
Strong interpersonal, communication, and organizational skills
Competency in electronic medical records and research databases

Preferred Skills and Competencies

Knowledge of clinical research protocols and regulatory frameworks
Ability to work independently and manage multiple priorities
Strong critical thinking and problem-solving abilities
Attention to detail with high standards of accuracy
Experience with data collection and clinical documentation systems

Physical & Work Environment Requirements

Ability to perform clinical procedures and prolonged standing
Occasional travel to community clinics or medical facilities
Exposure to biological specimens and clinical environments
Ability to work under infection control and safety protocols

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.

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