Institute for Medical Research at the Durham VA Health Care System

Clinical Research Coordinator

PI: Dr. Stephen Freedland

The Institute for Medical Research, an affiliate of the Durham VA Health Care System (DVAHCS) is looking for a Clinical Research Coordinator (CRC) 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.

This position is hybrid and candidates must be available to work Monday-Friday. There may be the option to work remotely up to three days each week as the clinic and recruitment schedules allow.

Location: This position is located in Durham, North Carolina. IMR employees must reside in the state of North Carolina or be willing to relocate prior to start date.

Critical Element 1

Oversee and coordinate select clinical research performed by the PI:

• Develop, implement, and direct study procedures for each study

• Coordinate with other hospital services such as urology, surgery, and pathology to facilitate research activities

• Oversee Clinical Trials Assistants and Data Technicians in identifying eligible patients for studies requiring case and healthy control subjects

• Oversee Clinical Trials Assistants in recruitment and consent study participants

• Demonstrate good judgment and problem solving to troubleshoot and modify protocol implementation when necessary, including barriers to study recruitment

• Provide input on clinical research projects related to budget, timelines, scheduling, staffing, and other relevant issues

• 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

• Supervise study personnel involved in patient enrollment and data collection including employees, students, residents, and fellows:

• Supervise study personnel, including multiple Clinical Trials Assistants and Data Technicians

• Interview, hire, and train new study personnel as needed. Maintain training and delegation logs

• Approve timecards, conduct performance reviews, troubleshoot technical problems, and respond to procedural questions

• Obtain and maintain WOC and VINCI status at the DVAHCS for self and other personnel

• Critical Element 3

• Liaise with Regulatory Coordinators 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 Regulatory team

  Critical Element 4

  Oversee organization, collection, and processing of human tissue specimens for select research studies:

• Assist with and train staff on procurement, processing, and shipping of urine, blood, and tissue specimens

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

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

• 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

• 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 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 DVAHCS

• 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:

• 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, 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

  Critical Element 7

  Manage day-to-day needs of the laboratory

• Monitor lab freezers, refrigerators, and storage cabinets

• Attend quarterly lab safety meetings sponsored by the VA

• Ensure compliance with VA lab requirements by conducting audits of specimen processing procedures, participating in VA sponsored audits and laboratory inspections, ensuring all safety procedures are followed by our staff and maintaining an up-to-date chemical inventory

• Manage laboratory by maintaining lab space and inventory, ordering study specific and general lab supplies, managing specimen bank, and supervising lab work

  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:

Education Requirements: Registered Nurse with 2+ years of clinical experience, certified Phlebotomy Technician with 5+ years of experience, or BS in a science field with 3+ years of site-side clinical research experience.

Skill Requirements :

• Experience managing personnel including daily supervision, training, performance reviews, and hiring/firing.

• Experience working in a clinical environment; understands the importance of clinic workflow and able to work diplomatically and professionally with administration, faculty, clinical and lab personnel, and research subjects.

• Demonstrated leadership, professional initiative, teamwork, strong interpersonal relationship skills, decision-making, and good judgment.

• Possess sufficient professional knowledge of clinic operations and general medical research to provide training and guidance to others in the clinic.

• Excellent written and oral skills, Windows, Microsoft Word, Excel, Access, editing, and proper telephone etiquette skills are required for this position.

• Prior experience with clinical research, FDA regulations, and HIPAA considerations is preferred.

• Requires an organized, task oriented, deadline-sensitive individual

• Must have the ability to work independently in a fast-paced environment, prioritize and manage the workflow of multiple projects,

• Must be able to occasionally lift at least 40 pounds, sit at a computer for long periods of time, and stand on your feet for long periods of time.

• Has fluency in the English language.

  Status: Exempt

  Salary range is $63,046.00-$81,307.60 annually and will be commensurate with experience level.

  This position is hybrid and candidates must be available to work Monday-Friday. There may be the option to work remotely up to three days each week as the clinic and recruitment schedules allow.

  Expected start date is typically 6 weeks following job offer and is contingent upon completion and processing of VA paperwork.

  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 and may be asked to complete a drug test and/or physical prior to hiring. We are an equal-opportunity employer.

  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/) !