Institute for Medical Research at the Durham VA Health Care System

Clinical Research Regulatory Coordinator

PI: Dr. Stephen Freedland

The Institute for Medical Research (IMR), an affiliate of the Durham VA Health Care System (DVAHCS), is looking for a full-time Clinical Research Regulatory Coordinator to manage regulatory compliance for clinical research studies conducted by the Principal Investigator, Dr. Stephen Freedland, and associates in his urology research lab. 

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

Duties and Responsibilities:

Preparation and submission of IRB and Research Office paperwork

• Prepare VA-specific protocol, informed consent form, HIPAA authorization, DUA, 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
• Works closely with research coordinator prior to completion of study specific documents
• Work with staff members to complete conflict of interest paperwork for each study
• Prepare and submit requests for access to nation-wide VA data via the VA Informatics Computing Infrastructure

Work with group members to complete required research training and paperwork

• Assist new hires in completing and submitting all required paperwork and trainings
• Track training status and Scopes of Practice of existing staff, assisting with updates as needed

Maintain electronic and paper documentation of regulatory paperwork and training

• Maintain study binder with all IRB related documents and correspondence for each study
• Maintain electronic regulatory files, including tracking document history
• Maintain a database of staff listings and training dates
• Maintain a list of study-specific funding sources

Assist with internal and external audits of regulatory compliance

• Coordinate internal audits of enrollment documents
• Coordinate meetings with VA and external auditors and monitors to review paper and electronic regulatory files, study binders, enrollment documents, and study documents
• Provide copies of IRB and contractual documents to collaborators, as needed

Non-critical Elements:

• Work effectively as part of a team
• Adhere to safety and compliance regulations
• Assist other research personnel

Qualifications:
Requires an associate’s degree with 3+ years of relevant experience or a bachelor’s degree and 1+ year of relevant experience.

Candidates must be able to work diplomatically and professionally with administration, faculty, and clinical personnel. Demonstrated attention to detail, ability to meet deadlines, professional initiative, teamwork, and reliability is expected. Excellent written and oral skills, Windows, Microsoft Word, Excel, editing, and proper telephone etiquette skills are required for this position. Experience with Microsoft Access is a plus. Prior experience with clinical research, FDA regulations, and HIPAA considerations is preferred.  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, and have fluency in the English language.

Physical Requirements: 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 10 pounds, 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 position of Clinical Research Regulatory Coordinator is under the direct supervision of the Clinical Research Regulatory Team Lead.

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: $48,000.00 - $57,000.00 per year

Status:  Exempt

Start Date:  Expected start date will be 4- 6 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 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 physical and 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.

Click here to apply to this position and others directly on the Institute for Medical Research Careers Page!