Clinical Research Nurse, Clinical Operations

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A Clinical Research Nurse (CRN) supports Principal Investigators (PI) in the day‑to‑day activities required for activation, execution, and management of clinical research studies or protocols. Active clinical licensure is required for duties expected to be directly performed by the Clinical Research Nurse. At Massey, the CRN has more complex and intensive participant contact in a clinical setting requiring an individual with high levels of clinical competency to perform the research‑related study work.

In addition to performing clinical skills associated with research studies, typical duties of a CRN include but are not limited to: assist the PI in assessing study feasibility, determining participation eligibility, and establishing guidelines for clinical data collection; serve as patient/participant recruiters; and perform a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data.

Massey Comprehensive Cancer Ctr MBU

Massey Clinical Trials Office

To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high‑impact, cutting‑edge research; person‑centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community‑centric researchers and healthcare professionals.

To be a premier community‑focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all.

• Recruitment, Enrollment, Retention, and Data Collection: A CRN drives study coordination and regulatory management with participant recruitment, enrollment, tracking, data collection, data processing/resolution (discrepancies, queries etc.), verification, case‑finding, evaluation, abstraction of source documentation, case report form completion, database use/management, data abstraction/organization and archiving of data in the study database for research studies. A CRN leads development of best practice guidance and work aids for their respective research team for all data management documentation following standard practice guidelines, utilizing multiple data capture/retrieval systems & interacting with a variety of health care delivery systems to identify, track, evaluate, collate, analyze/submit subject data.
  
  Data may include but is not limited to paper data, electronic data & biological specimens.
• Serve as a lead research coordinator for an emerging central coordinator pool, work with leadership to lay the groundwork for expanding a coordinator pool, and overall portfolio staffing and management.
• Maintain advanced understanding of clinical research management duties from initiation to closeout including but not limited to: federal and state laws and regulations, sponsor guidance as well as university policies and compliance notices, with ability to consistently interpret and apply accurately.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as well as any other mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training as required.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Follow VCU internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards, institutional operational research objectives are met and ethical obligations are kept.
• Serve as an ongoing resource providing information and expert advice on clinical research for the research team including but not limited to the clinical study team coordinator, peer Clinical Research Nurses, Clinical Research Coordinators, Clinical Data Manager, Sponsors and PI with other duties as assigned.

This role reports in‑person in downtown Richmond with the flexibility to…