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Research Coordinator - RN

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University of Rochester

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Location:
United States of America , Rochester

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Category:
Nursing

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Contract Type:
Not provided

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Salary:

35.35 - 45.96 USD / Hour
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Job Description:

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.

Job Responsibility:

  • 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
  • Perform quality assurance reviews to ensure consistency between source documents and case report forms (CRFs)
  • Screening, informed consent, eligibility reviews, outreach, and participant education
  • Source documentation, AE/SAE reporting, audit preparation, and regulatory submissions
  • Team meetings, protocol adherence monitoring, workflow optimization, and performance improvement initiatives
  • Data entry, filing, scheduling, inventory control, and study material management
  • Sponsor training, GCP certification, and continuing education
  • 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
  • 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
  • Monitor for protocol deviations and implement corrective actions as needed
  • Assist with audits and inspections by sponsors and regulatory authorities
  • 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
  • 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

Requirements:

  • Associate Degree in Nursing (ADN) required
  • 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

Nice to have:

  • Bachelor of Science in Nursing (BSN) preferred
  • 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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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