INSTITUTIONAL REVIEW BOARD (IRB) AND COMPLIANCE COORDINATOR Job at Aultman Health Foundation
PURPOSE OF POSITION
Under the general guidance of the Institutional Review Board (IRB) Chair and Director of Research Programs reviews and processes research applications in accordance with human subjects’ research regulations. Responsible for providing guidance to researchers on protocol design, project review and approval process, and reporting functions. The coordinator is responsible for communication and written correspondence regarding IRB actions.
Performs routine audits of research records to assess compliance with Good Clinical Practice guidelines, regulations, and study specific protocols. Documents findings in internal audit report. Communicates findings with investigators, study staff, Director of Research Programs and Research Oversight Committee.
Desirable Knowledge, Skills, Abilities and Personal Characteristics
- Scientific knowledge with basic medical terminology
- Independent decision making and critical thinking skills
- Willingness to learn
- Good attention to detail
- Ability to maintain confidentiality
RESPONSIBILITIES & EXPECTATIONS IRB Coordinator
- Serves as the institutional resource for IRB services.
- Screens study protocols and IRB related documents for completeness and conformance with institutional standards.
- Communicates with residents, physicians, nurses and ancillary departments regarding submission of IRB documents.
- Determines the type of IRB review required for each project.
- Performs and documents review of amendments, continuing review, and other reportable events.
- Administratively reviews projects whereby Aultman is not the IRB-of-record.
- Coordinates and attends IRB meetings including sending out review packets and monitoring meeting progress.
- Prepares and distributes bi-monthly IRB agenda.
- Records the decision-making process of the IRB in official minutes.
- Follows-up with investigators regarding conditions of approval and IRB actions.
- Develops training and education materials for the IRB members.
- Understands and remains current on relevant regulations, guidelines, and institutional policies to protect human subjects.
- Assists with revisions and implementation of IRB forms, policies and procedures, as well as other resources for the research community.
- Interacts positively with research participants and the research community.
- Maintains and manages IRB Manager™, an electronic database
- Performs internal auditing of research records to monitor compliance with regulations, guidance’s, IRB directives and protocol. Auditing is 40% of job.
- Creates and fosters a work environment that is consistent with the Mission, Vision and Values of the Aultman Health Foundation.
- Supports strategic organizational goals.
- Abides by the Aultman Code of Conduct at all times.
Job Requirements
- Registered Nurse, Licensed Practical Nurse, or bachelor’s degree in health science related field.
- Commitment to the importance of protecting the rights, safety and welfare of human research subjects.
- Proficiency in computers, word processing, and database software.
- Must be able to work effectively in a fast-paced environment, work on multiple concurrent inter-related projects. Able to prioritize competing projects and deadlines.
- Detail-oriented with excellent communication skills (both oral and written) and the ability to negotiate or communicate with clients, management, and researcher.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, or veteran status.
WORKING CONDITIONS:
- 8:00am—4:30pm M-F. 40 hours per week or 1.0 FTE.
- Subject to frequent interruptions and changes in priority of duties throughout the day.
- Sitting/standing/moving about during working hours
Location: Aultman Health Foundation · CLINICAL RESEARCH HRBB
Schedule: Full Time, Day Shift, 8A-4:30PM
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