Clinical Research Coordinator - Greenville

Institute for Medical Research at the Durham VA Health Care System Clinical Research Coordinator - 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 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 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. Location: This is an hybrid role with at least 2-3 days a week in-office. Candidate is required to work from our Greenville (NC) Veteran’s Affair location and must be willing to travel to the Durham, NC area for in-person onboarding and in-office activities. IMR employees must reside in the state of North Carolina. C andidates must be willing to relocate to North Carolina prior to start date. Critical Element 1 - Oversee and coordinate select clinical research performed by the PI:

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

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

Work together with Clinical Trials Assistants to recruit study participants, collect specimen and process samples

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 Durham and Greenville VA

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 Clinical Trial Assistants 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 – 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 7 – 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 or certified Phlebotomy Technician with 5+ years of 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.

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.

Candidates will work in-person in the Greenville clinic and laboratory. Candidates must be willing to travel to the Durham, NC area for in-person onboarding and in-office activities following lifting of COVID-19 restrictions.

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 6-8 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 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.

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/) !