The Institute for Medical Research, an affiliate of the Durham VA Health Care System (DVAHCS) is looking for a Clinical Research Coordinator to oversee select clinical research studies conducted by the Principal Investigator, Dr. Stephen Freedland, and his associates in his urology 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 urology studies primarily involving prostate cancer but may involve other diseases include bladder cancer and interstitial cystitis. Studies include prospective observational research, clinical trials, and related tissue and serum-based studies.
Critical Element 1
Oversee and coordinate select clinical research performed by the PI:
• 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
• Recruit and consent study participants with Clinical Trials Assistants
• 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
Liaise with Regulatory Assistant to maintain all IRB and regulatory paperwork for select clinical research performed by the PI at the DVAMC:
• Prepare and submit VA-specific protocol, informed consent form, HIPAA authorization, and other related documents for initial review by the IRB
• Prepare and submit amendments, yearly request for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions
• Coordinate with administrative staff to maintain study binder with all IRB related documents and correspondence for each study
• Screen documents and electronic case report forms for completeness and compliance with protocol and appropriate regulations; investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of data collected and follow-up with subjects as needed
Critical Element 3
Supervise study personnel involved in patient enrollment and data collection including employees, students, residents, and fellows:
• Supervise study personnel, including multiple Clinical Trials Assistants
• Interview, hire, and train new study personnel as needed. Maintain training and delegation logs
• Obtain and maintain WOC and VINCI status at the DVAMC for self and other personnel
• Approve timecards, conduct performance reviews, troubleshoot technical problems, and respond to procedural questions
Critical Element 4
Organize, Collect, Process, and Maintain human tissue specimens:
• Assist with and train staff on procurement, processing, and shipping of urine, blood, and tissue specimens
• Coordinate with other CRCs to ensure organization of all tissue specimens collected by your staff, including blood, serum, fat, prostate, urine, feces, and lymph nodes
• Facilitate shipping and receipt of specimens to and from external facilities
• Coordinate with other CRCs to ensure specimen processing is executed by staff. This includes DNA extraction, blood and urine centrifugation, and sample aliquoting
Critical Element 5
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 DVAMC
• Update and maintain master staff list, master project list, and SOPs for various tasks
• Participate in conference calls, weekly meetings with leadership, and other team meetings
• Help to prepare for monthly team-wide meetings
Critical Element 6
Work with IMR Administration to facilitate contracts for select clinical research performed by the PI at the DVAHCS:
• Ensure CRADA and statement of work language is consistent with other regulatory documents including data use agreements, consents, and protocols
• Coordinate with sponsoring group to develop SOPs, obtain CRADA approval, maintain appropriate study documentation and CRFs, and organize site visits
• Assist with budget development, contracts, and invoicing
• Track funds and approve invoices
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Skills and Experience:
Requires an organized, task oriented, deadline-sensitive individual with a minimum of a bachelor’s degree and a minimum of 1-2 years of relevant experience. Graduate education may be considered in lieu of work experience.
Candidates must be able to work diplomatically and professionally with administration, faculty, clinical and lab personnel, and subjects. Demonstrated leadership, professional initiative, teamwork abilities, strong interpersonal relationship skills, and decision-making, and good judgement is expected. Excellent written and oral skills, Windows, Microsoft Word, Excel, Access, editing, and proper telephone etiquette skills are required for this position. Incumbent should possess sufficient professional knowledge of clinical research to provide training and guidance to others in the clinic. Prior experience with clinical research, FDA regulations, and HIPAA considerations is preferred. Some basic wet lab experience is required. Salary will be commensurate with experience level. Applicant must have the ability to work independently in a fast-paced environment, prioritize and manage the workflow of multiple projects, lift up to 40 pounds, sit at a computer for long periods of time, and have fluency in the English language.
The prior statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Employees work for the Institute for Medical Research and will have an appointment at the Durham VA Medical Center. Please visit www.imr.org for information about employee benefits. Employees must undergo a Federal background check, drug test, and a physical prior to hiring. We are an equal-opportunity employer.