Clinical Research Coordinator

Benefits At a Glance

• Up to 5 remote days per month upon successful completion of training and leadership approval;
  
• Continuing education for undergraduate and graduate tuition for a maximum of 6 credits per semester;
  
• Professional development opportunities encouraged and offered for employees as part of annual career development, e.g. certifications, seminars, courses, annual conferences, mentorship;
  
• 28 Vacation Days, 12+ State Holidays, and 4 Days to volunteer;
  
• Medical, Dental and Vision Health Benefits to meet the needs of employees and their eligible family members from the Commonwealth of Virginia as well as optional FSA;
  
• Participation in the Virginia Retirement System (VRS) and other retirement saving options;
  
• Parental and Caregiver Leave, Short Term Disability (STD), Disability Insurance, Voluntary Long Term Care Insurance, and Employee Assistance Program.
  

Massey Comprehensive Cancer Center

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

Position Primary Purpose and General Responsibilities

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.

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 and ethical obligations are kept;
  
• 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;
  
• 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.