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Research Compliance Coordinator
Research Compliance Coordinator
Research & Sponsored Programs
Reporting to the Director of the Office of Research and Sponsored Programs, the Research Compliance Coordinator’s primary responsibilities include:
(1.) Providing specialized administrative support to Jacksonville University’s Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC)
(2.) Ensuring JU’s compliance with appropriate ethical, federal, state, and local requirements and best practices.
Essential Job Duties
Scope of Work
- Serves as liaison between the IRB and IACUC, Principal Investigators (PIs), study coordinators, and affiliate institutions, providing consultation and guidance to facilitate the ethical and regulatory conduct of human and animal subject research.
- Serves as the IRBNet database administrator, facilitating all submissions and correspondence to and from IRBNet.
- Develops and provides educational trainings and workshops for investigators, research personnel, and others to promote institutional compliance with research regulations.
- Thoroughly screens all research protocols to determine completeness and consistency with federal regulations, state laws, and institutional policies. Ensures any issues related to compliance are sufficiently resolved prior to IRB/IACUC review.
- Determines and compiles meeting agendas and minutes to meet distribution deadlines, disseminates meeting agendas and packets, coordinates and attends meetings. Also assists in assuring that membership and quorum rules are enforced.
- Records the decision making process of the IRB and the IACUC in official minutes, capturing and documenting summarization of any controverted issues and their resolution, succinctly recording meeting actions and indicating exactly what was approved. Records the specifications of modifications required to obtain approvals, the degrees of risk, attendees, votes on actions, names of members who abstain, names of members who absent themselves due to conflict of interest, attendance at the meeting for each action, basis for requiring a change in research, basis for disapproval of research, the rationale for significant or non-significant risk determinations, approval periods and other regulatory requirements.
- Communicates IRB/IACUC administrative actions and requests to Principal Investigator, and drafts other correspondence as needed in an organized, clear, concise manner including issues related to compliance.
- Maintains study files and work log, ensuring documentation of all actions and communications with investigators and study personnel is filed appropriately
- Manages required CITI training modules (Human Subjects Research, Animal Care and Use, Responsible Conduct of Research, and Conflict of Interest) and verifies training certifications are current before final IRB/IACUC approval is issued.
- Conducts annual audit of IRB and IACUC records and files to verify the accuracy of official documents.
- Maintains the University’s HHS IRB Registration and the Office of Human Research Protections (OHRP) Federalwide Assurance (FWA).
- Reads literature, attends training sessions, and other functions to keep abreast of relevant scientific, regulatory, and technical developments related to human and animal research.
- Assists the Director with the strategic planning and introduction of new initiatives to stimulate research at the JU.
- Contributes to the further development of efficient systems and procedures to enhance research activity.
- Develops and maintains policies, procedures and bylaws relevant to the policies and procedures relevant to the IRB and the IACUC,
- Performs other duties as assigned.
Prerequisites Required For Position
Minimum Education and Experience
- Bachelor’s degree in the health sciences or a related field, or an equivalent combination of experience, education and/or training.
- Two (2) years of experience in a research environment.
- Prior work in human subject research or research compliance, protocol writing and/or document review.
- Certified IRB Manager (CIM), Certified IRB Professional (CIP), or equivalent certification is preferred.
Required Knowledge, Skills, and Abilities
- Must have demonstrated knowledge and understanding of the IRB process.
- Professional demeanor; respectful of others; commitment to ethics and integrity; ability to demonstrate tact and good judgement.
- Impeccable written and oral communication skills.
- Solid PC skills including knowledge of MS Office functions and electronic database tracking systems, such as IRBNet.
- Outstanding interpersonal and management skills, a collaborative style, and experience working with faculty, staff, and students in achieving their research goals.
- Must be customer-service oriented, proactive in estimating faculty needs and questions, and highly responsive to all requests/inquiries.
- Excellent analytical, organizational, and proofreading skills.
- Excellent time management skills, aptitude for proper task prioritizations and a results-oriented work process.
- Working knowledge of the Common Rule (45 CFR 46), FDA regulations, FERPA, HIPAA and other relevant requirements and guidelines related to the ethical study of human research subjects.
- Ability to maintain strict confidentiality and handle sensitive information with absolute discretion.
- Ability to plan and present educational sessions to diverse groups of students, faculty and staff.
- Flexibility to work occasional nights and weekends to meet deadlines, if needed.
For serious consideration as a qualified candidate, an applicant should have IRB or Clinical Research experience. A Cover Letter to the Director, a Resume, the JU Background Check Authorization, and a completed JU Employee Staff Application is required of all applicants. Please submit materials to ORSP@JU.EDU