Clinical Research Coordinator 4 - Licensed or Non-Licensed - Cardiovascular Medicine, Electrophysiology
Job ID: R0031557 | Clinical Research | Full Time | Charlottesville, VA
Clinical Research Coordinator – 4, Non-Licensed (CRC-4, NL): Plan, organize, lead and perform comprehensive and advanced-level clinical research duties for multiple and/or complex clinical trials. A CRC 4 has the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective department or division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs.
  • Manage multiple principal investigator relationships with internal and external research stakeholders.
  • Provide guidance and assistance to principal investigators for grant submissions, budget management and research compliance oversight to ensure full compliance with local, state and federal policies and procedures.
  • Serve as the primary liaison with the sponsor for assigned studies.
  • Assist principal investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators and industry or government sponsor.
  • Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity.
  • Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval.
  • Participate in planning and analysis of research portfolios in conjunction with department management and principal investigators.
  • Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation and quarterly review of all principal investigator accounts.
  • Manage a team of Clinical Research Coordinators and/or laboratory or research support staff with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development and performance management.
  • Coordinate clinical research education, training and/or orientation for new faculty, fellows, residents or medical students.
  • Develop administrative and financial recommendations for department management and principal investigators for research portfolio review.
  • Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions.
  • Participate in at least one research-related working group at the institutional level or lead a process-improvement initiative at a department or division level.
  • Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations.
  • In addition to the above job responsibilities, other duties may be assigned.

MINIMUM REQUIREMENTS
  • Education: Bachelor's degree required. Master's or other advanced degree preferred.
  • Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience.
  • Licensure: None.

PHYSICAL DEMANDS
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings and programs.


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Charlottesville, VA
Charlottesville, VA 22903

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