Campbell University College of Pharmacy & Health Sciences
Location: Buies Creek, North Carolina
Type: Full Time
Required Education: 4 Year Degree
Academic / Research
College / University
Internal Number: 001
The IRB Coordinator will serve as the primary contact and initial resource for investigators, faculty, and staff at Campbell University and partner organizations. A firm understanding of human subject research regulations and federal guidance documents is critical. Work is completed in accordance with the approved university processes and procedures that ensure compliance with federal and state regulations and institutional policies relative to human subjects research. The incumbent is a staff member of the Provost’s Office and reports to the Assistant Provost for Administration.
Essential Duties and Responsibilities:
The IRB Coordinator shall perform the following primary IRB functions in support of research protocols:
Review new research applications for consistency, completeness, and compliance with Federal and state regulations and institutional guidelines prior to convened IRB review.
Review all complete project submissions, verify review type, recommend assignment of reviewers, and verify exempt status based on university guidelines.
Review Informed Consent Documents (ICDs) for protocol and amendment?specific content and to ensure presence of federally mandated elements of informed consent.
Communicate to Principal Investigators items that require clarification, or documents required for submission, to complete a research application for IRB review.
Write correspondence to Principal Investigators to communicate the decisions of the IRB.
Evaluate reports of unanticipated problems, amendments and continuing review forms, and prepare correspondence for review by the committee.
Report serious non?compliance issues to the IRB chair and/or the Research Integrity Officer of the university.
Monitor the regulatory environment and recommend changes, as needed, to the university and IRB chair.
The IRB Coordinator shall perform the following IRB administrative duties in support of Institutional Review Board operations:
Coordinate with the IRB chair to produce the monthly IRB agenda for each meeting and ensure that materials are distributed within established guidelines.
Work with other members of the IRB, attend IRB meetings, record deliberations, and write meeting minutes. Ensure that minutes for each meeting are accurately recorded; finalize minutes for IRB Chair approval.
Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.
Assist with training and orientation tasks of new committee members.
The IRB Coordinator shall perform the following additional functions, as needed, in support of Institutional Review Board operations:
Attend seminars, workshops, and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations.
Participate in, or present at, research?related educational sessions for faculty and staff of Campbell University.
Work collaboratively with the IRB Chair to facilitate ongoing development, implementation, and maintenance of the Human Research Protection Program.
This position demands accuracy, honesty, integrity and the ability to work with the Christian mission of Campbell University.
Maintain a professional appearance and demeanor at all times.
Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
Minimum of a Bachelor’s degree required.
Must have knowledge of, and experience in, the interpretation of Federal and State regulations particularly regarding the protection of human subjects (to include working knowledge of Federal regulations for human research: 21 CFR parts 50, 56, 312, and 812; and 45 CRF 46).
Experience in designing, operating and implementing electronic IRB applications.
Experience in a higher education or non-profit sector is also preferred.
Knowledge, Skills, and Abilities:
Must possess excellent written and verbal skills, as well as strong problem solving and decision making skills.
Must possess discretion and mature judgment as confidential information is routinely encountered.
Proficient with relevant computer programs.
High level of experience and comfort working independently with senior leadership, faculty, staff, students, medical professionals and external agencies in complex organizations.
Ability to interpret laws and regulations to ensure overall protection of human participants.
Ability to advise on matters of general research compliance and ethical human participant research practices.
Ability to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities.
Ability to acquire quickly a broad knowledge of Campbell University policies and procedures and FERPA guidelines.