Clinical Research Coordinator, Clinical Operations, Restricted

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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 of a Clinical Research Coordinators include but are not limited to: assisting the PI in assessing study feasibility, determining participation eligibility, and 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 includes responsibilities of the CRC to work independently and as a member of a team.

Working under general supervision, a CRC resolves most standard issues independently and refers complex issues to an upper-level manager or the PI, as appropriate. This role reports in-person in downtown Richmond or Stoney Point with the flexibility to work hybrid 5 days/month post-review, 3-6 months 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

Mission:
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.

Vision:
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 CRC 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 CRC leads 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 & 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.

• Engage in various forms of communication about the studies they are assisting; engage in 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 system 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 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;
• 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…