Clinical Research Coordinator, Clinical Operations, Restricted

Clinical Research Coordinator (CRC)

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Summary:

Clinical Research Coordinators (CRC) support Principal Investigators (PI) in the day-to-day activities required for activation, execution, and management of clinical, patient-oriented research studies or protocols. Typical duties include assisting the PI in assessing study feasibility, determining participation eligibility, establishing guidelines for clinical data collection, serving as patient/participant recruiter, and performing a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data.

CRCs coordinate the evaluation, treatment, and follow-up of clinical trial candidates and participants in inpatient and ambulatory settings, educating staff at local and partner sites about clinical trials and related patient care while consulting with physicians/staff about patient care issues. This role involves working independently as well as within a team, resolving most standard issues and referring complex matters to an upper-level manager or the PI as needed.

The position reports in person in downtown Richmond or Stoney Point with flexibility to work hybrid up to 5 days per month following training and manager approval. Each CRC reports to a Clinical Operations Manager who oversees disease working group specific teams within the Clinical Research Operations Unit.

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.

• Drive study coordination and regulatory management with participant recruitment, enrollment, tracking, data collection, data processing/resolution, 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.
• Lead development of best practice guidance and work aids for CRCs for all data management documentation following standard practice guidelines, utilizing multiple data capture/retrieval systems and interacting with a variety of health care delivery systems to identify, track, evaluate, collate, analyze, and submit subject data.
• Engage in various forms of communication about the studies, including effective communication with the study's Hub Site, community partners, community organizations, social media outlets, research participants, and others.
• Work collaboratively and independently to develop electronic clinical research charts, conduct data retrieval, entry, and quality control using eMR, CTMS (OnCore), other IT systems, and supporting documentation.
• Ensure trial visits, data for study participant tests and samples are done per the study schedule and entered in a timely fashion.
• Maintain advanced understanding of clinical research management duties from initiation to closeout including federal and state laws and regulations, sponsor guidance, university policies, compliance notices, and the ability to consistently interpret and apply them accurately.
• Follow VCU internal processes to ensure compliance with VCU policies related to research activities and with federal and state regulatory standards, meeting institutional operational research objectives and ethical obligations.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, and other sponsor GCP certifications as required by VCU, VCUHS, individual clinical trials, and NIH Human Subjects Protection training.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB-approved protocols.
• 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, Clinical Research Nurse, peer Clinical Research Coordinators, Clinical Data Manager, sponsors, and PI with other duties as assigned.

• Minimum:
  Bachelor's degree in health research and/or healthcare-related fields or equivalent combination of education, experience, and training.
• 2+ years of relevant experience supporting data management activities with exposure to data processes and flow or equivalent combination of education, training, and experience with the ability to learn basic data entry, understand complex protocols, and motivation to learn the foundation of at least one oncology disease area.
• 2+ years experience with…