Institute for Medical Research at the Durham VA Health Care System

National Prospective - Clinical Research Coordinator I

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 and oncology research lab. This includes management of select nationwide prospective projects, personnel hiring and training, compilation and documentation of data and tissue, and preparation of IRB and regulatory paperwork, among other responsibilities.

The CRC will be responsible for management of several studies, across a breadth of urology and oncology areas. These studies entail 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 CRC supervision. 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 position a Hybrid position, in office 2 days a week.

This position is located in Durham, NC. Candidates must live in North Carolina or be willing to relocate before start date.

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 - 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 DVAHCS

• 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 patient outreach staff 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 to urine, blood, and pathology tissue specimens

• Participate in the selection, vetting, and onboarding of third-party vendors

• Facilitate shipping and receipt of specimens per contract and protocol guidelines

• Ensure chain of custody requirements are understood by all staff and completed per Sponsor guidance

• Ensure study kits are maintained per Sponsor guidelines, up to and including final disposition of all kits

• 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 research staff to ensure organization of all tissue specimens collected

  Critical Element 6 – Help to maintain all IRB and regulatory paperwork for select clinical research performed by the PI at the DVAHCS:

• Review and coordinate with the Regulatory team and Sponsor on preparation of study protocols, informed consent forms, HIPAA authorization forms, and other related documents for IRB review and study execution

• Coordinate with the Regulatory team and Sponsor on all protocol amendments, yearly continuing reviews, audits, adverse event reports, and any other IRB-required submissions

• Coordinate with study monitor(s) 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

• Create interest letters, phone scripts, patient questionnaires, and any other documents necessary for successful study execution in collaboration with study Sponsors and the Regulator team

  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.

  Salary Range or Rate of Pay : $55,500.00 to $75,926.95 annually and is commensurate with experience and/or education.

  Status: Exempt

  Candidates will have a mix of remote work and in-person work in our office and laboratory. Candidates must be willing to relocate to the Durham, NC area for in-person onboarding and in-office activities following lifting of COVID-19 restrictions.

  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.

  Start Date: Expected start date will be 8 weeks after the offer but is somewhat flexible and contingent upon completion and approval of VA paperwork.

  Employee Benefits: IMR offers a competitive benefits package if you work 30 hours or more which includes health, dental, vision, short- and long-term disability insurance. IMR offers a matching 403b retirement savings plan if you work 20 or more hours. Both part-time and full-time employees get paid holiday, vacation, and sick leave. Please visit https://imr.org/benefits/ for information about employee benefits.

  All IMR employees are required to obtain a 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 physical and drug test. Participation in the vaccination programs may be required for all Department of Veterans Affairs Health Care Without Compensation (WOC) appointments. We will not sponsor applicants for work visas.

  Equal Opportunity Employer, including disabled persons and Veterans.

  Click here (https://imr.org/careers/) to apply to this position and others directly on the Institute for Medical Research Careers Page (https://imr.org/careers/) !