Institutional Review Board Coordinator

Full Time

40 Hours/Week

Monday - Friday, 8:00am - 5:00pm

Hybrid, 2 days/week onsite

Summary:

The IRB Coordinator is Responsible for supporting the activities of the Institutional Review Board by ensuring that human subjects research receives the required level of Institutional review and that project submissions are complete and ready for the Board's review prior to assigning reviewers. The IRB Coordinator also assists the Office of Research Integrity Manager in ensuring that investigators conduct the research in compliance with federal, state, and local regulations as well as institutional policies, and that the rights, safety and welfare of study participants are protected.

Responsibilities:

1. Provides support to the Institutional Review Board by: managing and triaging the study submission queue and assigning ancillary reviews when required; conducting pre-review analysis of study submissions to ensure that submissions are complete and compliant with regulations and Institutional policies prior to final review by the IRB; determining the appropriate level of review and assigning qualified reviewers; preparing and distributing meeting agenda, and taking thorough minutes of IRB proceedings; notifying investigators of Board decisions.
2. Supports investigators and the hospital community by providing regulatory and policy guidance as well as assistance with the submission process for internally and externally initiated research.
3. Serves as an administrator of the electronic IRB submission system and provides technical support to users. .
4. Serves as a liaison with technical staff to maintain and update the IRB website and content and facilitate its use by investigators and IRB members.
5. Coordinates with other members of the Research Institute staff to promote an integrated approach to the conduct and oversight of research.
6. Other duties as required.

Other information:

Technical Expertise

1. Experience in IRB procedure and human subjects protection is required.
2. Experience in international ethical codes, state and federal standards and guidance governing regulations related to human subjects protection, IRB submissions, informed consent process, protocol adherence and adverse event reporting and the conduct of clinical studies is required.
3. Excellent oral and written communication skills are required.
4. Experience with electronic IRB submission systems is preferred.
5. Experience working with individuals at all levels within an organization is required.
6. Experience in healthcare is preferred.
7. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.

Education and Experience

1. Education: Bachelor's degree in related field is required; Master's degree is preferred.
2. Certification: Certified IRB Professional [CIP] is preferred.
3. Years of relevant experience: a minimum of 3 years is required
4. Years of experience supervising: None required.

Full Time

FTE: 1.000000