Institute for Medical Research at the Durham VA Health Care System

Clinical Research Nurse - 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 Nurse 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 projects and clinic personnel, collection of clinical data from study participants, development of SOPs, preparation of IRB and regulatory paperwork, and protocol development including designing CRFs, compilation and documentation of data. The Clinical Research Nurse will assist with contract development and study design, as needed. 

The Clinical Research Nurse 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 position will report to the Research Manager and may supervise other study staff, including patient-facing nursing and phlebotomy staff.

Location: This is a hybrid role with at least 2-3 days a week in-office but more days in-office could be required depending on clinic needs. Candidate is required to work from our Greenville, NC Veterans Affairs location. Candidate must be willing to travel periodically to the Durham, NC area for in-person onboarding and quarterly 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 assist in coordinating activities in support of select clinical research performed by the PI and collaborators:

• Coordinate with other hospital services such as urology, surgery, and pathology to facilitate research activities
• Undertake advance planning with the drug research pharmacist (when appropriate) for dispensing of research-related medications or study devices
• Complete patient blood draws, collect vital signs, and report clinical data for research participation
• Provide input on clinical research projects related to budget, timelines, scheduling, staffing, and other relevant issues
• Work together with Clinical Trials Assistants to recruit study participants, collect specimen, and process samples
• Participate in the selection, vetting, and onboarding of third-party vendors
• Coordinate with study sponsors, contractors, other PIs, and research team members as part of sponsored or multi-PI studies

Critical Element 2 - Collaborate with research team, including other Clinical Research Coordinators (CRCs), and work effectively with team members

• Facilitate communications between study subject and other care providers when needed
• Broaden recruitment efforts by developing relationships within the Department of Urology and with the appropriate ancillary services such as the Hospital Laboratory, Pharmacy, Radiology, etc.
• Make decisions about day-to-day operations related to specific study protocols
• Oversee local clinic logistics and provide input on broader initiatives as needed
• 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

• Coordinate and proctor training for all research staff including phlebotomy, vital signs measurement, body measurements, and execution of other clinic-based research procedures
• Conduct clinical reviews with staff to assess diagnoses, treatments, and other findings
• Approve timecards, conduct performance reviews, troubleshoot problems, respond to procedural questions
• Interview, hire, and train new study personnel as needed. Maintain training and delegation logs
• Provide mentorship to mid-level managers to develop research, administrative, and managerial skills

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 – 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
• Be available for any after-hours lab-related issues such as critical equipment malfunction
• Manage laboratory by maintaining lab space and inventory, ordering study specific and general lab supplies, managing specimen bank, and supervising lab work
• Facilitate annual preventative maintenance tasks for laboratory equipment including pipettes, centrifuge, and freezers

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 Regulatory 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:

Education Requirements: Registered Nurse with 2+ years of clinical experience

Skill Requirements:

• Experience managing personnel including daily supervision, training, performance reviews, and hiring/firing.
• Understanding of medical terminology
• Proficiency in clinical data collection practices such as collecting blood and obtaining vital signs.
• 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.
• Fluent 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.

Salary Range or Rate of Pay: $63,046.00-$81,307.60 annually. Salary commensurate with experience level.

Status:  Exempt 

Start Date:  Expected start date will be 8-10 weeks after the offer is accepted but is somewhat flexible and contingent upon completion and approval of VA paperwork.

Employee Benefits: IMR offers a competitive benefits package which includes health, dental, vision, short and long term disability insurance. IMR offers a matching 403b retirement savings plan, and 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.