Institute for Medical Research at the Durham VA Health Care System
Clinical Research Coordinator - Greenville
PI: Dr. Stephen Freedland
The Institute for Medical Research, an affiliate of the Durham VA Health Care System (DVAHCS), is looking for a Prospective Clinical Research Coordinator to oversee select clinical research studies conducted by the Principal Investigator, Dr. Stephen Freedland, and his associates in his urology and oncology research lab. This includes development of SOPs, preparation of IRB and regulatory paperwork, protocol development including designing CRFs, compilation and documentation of data, and management of projects/personnel. The CRC will assist with contract development and study design, as needed.
The CRC will be responsible for management of several studies primarily related to urological or oncological diseases such as prostate cancer, bladder cancer, and lung cancer. Studies include prospective observational research, clinical trials, and related tissue and serum-based studies. The incumbent to this position will have the opportunity to work with a highly productive and dynamic team of MDs, PhDs, and clinical trials personnel. Seminars and other learning opportunities, including professional development funding as early as three months into employment, are also available. This is a supervisory role overseeing Research Team Leads, who manage Clinical Trials Assistants and Data Technicians.
Location: This is an hybrid role with at least 2-3 days a week in-office. Candidate is required to work from our Greenville (NC) Veteran’s Affair location and must be willing to travel to the Durham, NC area for in-person onboarding and in-office activities.
IMR employees must reside in the state of North Carolina. Candidates must be willing to relocate to North Carolina prior to start date.
Critical Element 1 - Oversee and coordinate select clinical research performed by the PI:
• Coordinate with other hospital services such as urology, surgery, and pathology to facilitate research activities
• Provide input on clinical research projects related to budget, timelines, scheduling, staffing, and other relevant issues
• Develop, implement, and direct study procedures for each study
• Assist with identifying eligible patients for studies requiring case and healthy control subjects
• Oversee Clinical Trials Assistants and Data Technicians in identifying eligible patients for studies requiring case and healthy control subjects
• Work together with Clinical Trials Assistants to recruit study participants, collect specimen and process samples
• Demonstrate good judgement and problem solving to troubleshoot and modify protocol implementation when necessary, including barriers to study recruitment
• Coordinate with study sponsors, contractors, other PIs and research team members as part of sponsored or multi-PI studies
• Coordinate with technical team for maintenance, testing, and improvement of research database(s)
Critical Element 2 - Collaborate with research team, including other CRCs, and work effectively with team members
• Make decisions about day-to-day operations related to specific study protocols.
• Make recommendations about program development, employee performance, and larger scale operations of the research group
• Coordinate with other CRCs to ensure overall study objectives are met for all clinical research at the Durham and Greenville VA
• Update and maintain master staff list, master project list, and SOPs for various tasks
• Participate in conference calls, weekly meetings with the PI, and other team meetings
• Prepare for and lead regular team meetings
Critical Element 3 - Supervise study personnel involved in patient enrollment and data abstraction including employees, students, residents, and fellows
• Supervise study personnel, including Clinical Trial Assistants and Data Technicians
• Interview, hire, and train new study personnel as needed. Maintain training and delegation logs
• Obtain and maintain WOC and VINCI status at the DVAHCS for self and other personnel
• Approve timecards, conduct performance reviews, troubleshoot problems, respond to procedural questions
Critical Element 4 - Work with IMR Administration to facilitate contracts for select clinical research performed by the PI at the DVAHCS
• Help to ensure contract and statement of work language is consistent with other regulatory documents including data use agreements, consents, and protocols and internal workflows
• Coordinate with sponsoring group to develop SOPs, generate invoices for completed research tasks and milestones, maintain appropriate study documents, , and organize site visits
• Assist with budget developments, contracts, and invoice supporting documentation
• Track funds and approve invoices
Critical Element 5 – Organize, Collect, Process, and Maintain human tissue specimens:
• Assist with and train staff on procurement, processing, and shipping of specimens, including but not limited
Location: Greenville, NC
Posted: Oct. 25, 2024, 4:06 a.m.
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