Clinical Research Coordinator I @ Institute for Medical Research, NC

The Institute for Medical Research, 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 Investigators, Drs. Tighe, Shofer, and Navuluri. This includes development of SOPs, preparation of IRB and regulatory paperwork, recruitment of participants for human subject research, 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 research studies.

Location: This position is located in Durham, North Carolina and candidates must be willing to relocate prior to start date. This position is primarily in-person and candidates must be available to work Monday-Friday.

Duties and Responsibilities:

Oversee and coordinate select clinical research performed by the PIs:

• 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
• Coordinate participant reimbursements for participation in research studies
• 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 DVAMC:

• 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 your staff, including blood, serum, fat, urine, feces, and lymph nodes
• Facilitate shipping and receipt of specimens to and from external facilities
• Coordinate with other CRCs to ensure specimen processing is executed by staff. This includes DNA extraction, blood and urine centrifugation, and sample aliquoting

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 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 an organized, task oriented, deadline-sensitive individual with a minimum of a bachelor’s degree and a minimum of 1-2 years of relevant experience.
• Graduate education may be considered in lieu of work experience.

Additional Requirements:

• 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 and videoconferencing 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.

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