Clinical Research Coordinator I – National Prospective
Institute for Medical Research at the Durham VA Health Care System
CLINICAL RESEARCH COORDINATOR I – National Prospective
PI: Dr. Stephen Freedland
The Institute for Medical Research, an affiliate of the Durham VA Health Care System (DVAHCS) is looking for a National Prospective 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 preparation of all IRB and regulatory paperwork, compilation and documentation of data and tissue, and management of projects/personnel.
The CRC will be responsible for management of potentially several urology studies involving prostate cancer. These studies have retrospective and prospective observational research components and involve phone-based recruitment of patients nationwide. There is little to no patient contact in this role, as most study activities will be conducted by staff under your supervision.
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
- Oversee the phone-based recruitment and consent process for study participants
- 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 – 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 requests 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 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 – Organize, Collect, Process, and Maintain human tissue specimens:
- Assist with and train staff on procurement, processing, and shipping of urine, blood, and tissue specimens
- Facilitate shipping and receipt of specimens to and from external facilities
- Oversee specimen processing as required by research protocols and coordinate with other CRCs to ensure specimen processing is executed by staff. This includes DNA extraction, blood and urine centrifugation, and sample aliquoting
- Coordinate with other CRCs to ensure organization of all tissue specimens collected by staff, including blood, serum, fat, prostate, urine, feces, and lymph nodes
Critical Element 4 – 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 the PI, and other team meetings
- Help to prepare for monthly team-wide meetings
Critical Element 5 – Supervise study personnel involved in patient enrollment and data abstraction 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, respond to procedural questions
Critical Element 6 – Work with IMR Administration to facilitate contracts for select clinical research performed by the PI at the DVAMC
- 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 SOP, obtain CRADA approval, maintain appropriate study document, CRFs, and organize site visits
- Assist with budget developments, 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 2-5 years of relevant experience in clinical research. Graduate education may be considered in lieu of work experience.
Candidates must be able to deal 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 professional knowledge of clinical research sufficient 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 salary range for this position is $49,000 – $63,500 annually and is commensurate with experience and/or education. Candidates must be willing to relocate to the Durham, NC area.
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.
The physical requirements and activities that are required to perform the essential functions of the position include, but may not be limited to, as follows: Must be able to occasionally lift, pull and push a minimum of 25 lbs., stand for extended periods of time, sit for extended periods of time, squat, kneel, and stoop, regularly use fingers, hands for computer work.
Supervisory Controls: The National Prospective Clinical Research Coordinator position falls under the direct supervision of the Research Manager.
Employee Benefits: IMR offers a competitive benefits package which includes health insurance, a matching 403b retirement savings plan, and paid holiday, vacation, and sick leave. Please visit www.imr.org for information about employee benefits.
All IMR employees are required to obtain a Workers Without Compensation (WOC) appointment at the Durham VA Health Care System (DVAHCS). As a result, the successful candidate must undergo a federal background check and may be subject to a drug test. Participation in the vaccination programs may be required for all Department of Veterans Affairs Health Care Workers Without Compensation (WOC) appointments. We will not sponsor applicants for work visas.
Equal Opportunity Employer, including disabled persons and Veterans.
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