Clinical Research Coordinator I - Infectious Diseases

Institute for Medical Research at the Durham VA Health Care System

Clinical Research Coordinator I – Infectious Diseases

PI: Dr. Christopher Woods

The Institute for Medical Research (IMR), an affiliate of the Durham VA Health Care System (DVAHCS), is looking for a full-time Clinical Research Coordinator I to oversee select Clinical Research studies conducted by the Principal Investigator, Dr. Christopher Woods, and associates in the Infectious Diseases department. This includes development of SOPs, preparation of IRB and regulatory paperwork, protocol development including designing CRFs, compilation and documentation of data, and management of research projects. 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 Infectious Diseases, such as pneumonia, sepsis, tick-borne infections, and COVID, and vaccines. Studies include prospective observational research, clinical trials, and related tissue and serum-based studies.

Location: This position is in-office and is located in Durham, North Carolina. Candidates must be a North Carolina resident or willing to relocate prior to start date.

Duties and Responsibilities:

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
• Recruit and consent 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

Prepare and maintain all IRB and regulatory paperwork for select Clinical Research performed by the PI at the DVAHCS:

• Prepare and submit VA-specific protocol, informed consent form, HIPAA authorization, and other related documents for initial review by the IRB
• Prepare and submit amendments, yearly request for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions
• Coordinate with administrative staff to maintain study binder with all IRB related documents and correspondence for each study
• Screen documents and electronic case report forms 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

Organize, Collect, Process, and Maintain human tissue specimens:

• Assist with and train staff on procurement, processing, and shipping of urine, blood, and tissue specimens
• Coordinate with other CRCs to ensure organization of all tissue specimens collected by staff, including blood, swabs, and in some scenarios, urine and stool
• Facilitate shipping and receipt of specimens to and from external facilities
• Coordinate with other CRCs to ensure specimen processing is executed by staff

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 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 DVAMC
• Update and maintain SOPs for various tasks
• Participate in conference calls, weekly meetings with leadership, and other team meetings
• Help to prepare for monthly team-wide meetings

Work with IMR Administration to facilitate contracts for select Clinical Research performed by the PI at the DVAHCS:

• Ensure CRADA and statement of work language is consistent with other regulatory documents including data use agreements, consents, and protocols
• 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

Qualifications:

• Requires a minimum of bachelor s degree and 1-2 years of relevant experience.

Additional Requirements:

• Requires an organized, task oriented, deadline-sensitive individual
• Candidates must be able to work 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 sufficient professional knowledge of Clinical Research 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.
• Applicant must have the ability to work independently in a fast-paced environment, prioritize and manage the workflow of multiple projects.

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 25 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 CRC I is under the direct supervisor of the PI and CRC III/CRNC.

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:$49,000 - $63,000 per year

• Salary will be commensurate with experience level.

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!