RESEARCH IRB COORDINATOR

RESEARCH IRB COORDINATOR

About Us:

At Sinai Health System d/b/a Sinai Chicago, we take health care personally. Excellence in health care is about more than just medicine, technology, tests, and treatments, it is about really caring for people with dignity and respect. That is what we do. We are dedicated to providing the best care to meet the needs of people, for our community, for our patients and for you.

Position Purpose:

The IRB Coordinator manages the day-to-day administrative, regulatory, and educational operations of the Mount Sinai Hospital Institutional Review Board (MSH-IRB) using the Cayuse cloud-based human subjects protection/IRB module. The Coordinator ensures that all human subjects research protocols are reviewed and approved in compliance with federal regulations (45 CFR 46, 21 CFR Parts 50, 56, 312, and 814), applicable ICH-GCP guidelines, and MSH-IRB and related institutional policies. The Coordinator provides expert regulatory guidance to investigators and research staff, supports the full Board and expedited/exempt review processes, and serves as the primary liaison among researchers, IRB Board members, and federal regulatory authorities. The coordinator will assist, if appropriate, the RTO Manager and or CRO-provided investigators and trials staff in communications/coordination with central IRBs or trial sponsors.

Key Job Activities:

Protocol Review and Regulatory Administration:

· Reviews and processes initial protocol submissions, amendments/modifications, continuing review applications, adverse event/unanticipated problem reports, protocol deviations for completeness and regulatory compliance, and closures prior to IRB consideration.

· Determines an appropriate review pathway (exempt, expedited, or full board) in accordance with 45 CFR 46 and 21 CFR Part 56 criteria, consulting with the IRB Chair as needed.

· Using the Cayuse platform, prepares and distributes Board meeting agendas, primary reviewer assignments, and protocol packets; record accurate and complete IRB meeting minutes reflecting determinations, required modifications, and stipulations.

· Issues IRB approval letters, stipulation response letters, and continuing review correspondence in compliance with applicable regulatory deadlines and institutional templates.

· Maintains a master tracking system for all active protocols, approval expirations, renewal due dates, and outstanding stipulations to ensure no lapses in IRB coverage.

Informed Consent and Participant Protection:

· In conjunction with the RTO Manager, reviews informed consent documents (ICDs) and assent forms for pharmaceutical trials or medical device studies, and federally funded trials research to ensure compliance with 21 CFR Part 50, 45 CFR 46.116–117, and ICH E6(R3) standards.

· In non-trial research, reviews informed consent documents (ICDs) and assent forms to ensure compliance with MSH-IRB rules and applicable federal rules.

· Evaluates consent documents for readability, appropriate language, required elements, and suitability for Sinai’s diverse patient populations, including non-English-speaking and low-literacy participants.

· Manages HIPAA Authorization review processes and research waivers and authorizations in Cayuse.

· Ensures vulnerable population protections (prisoners, children, pregnant women, cognitively impaired individuals) are appropriately addressed if included in protocols.

Clinical Trials and Sponsor Relations:

· Serves as the institutional IRB point of contact regarding protocol questions, IRB submission requirements, and approval timelines for pharmaceutical sponsors, contract research organizations (CROs), and medical device manufacturers, consulting with the IRB Chair or the RTO Manager where appropriate.

· Supports FDA-regulated IND and IDE trials by ensuring IRB processes align with 21 CFR Parts 312 and 814 requirements, including sponsor notifications, safety reporting, and FDA correspondence.

· Coordinates with the Research Trials Office (RTO) on their study activation timelines, protocol-specific training requirements, and regulatory binder maintenance.

· Supports the RTO Manager with ClinicalTrials.gov registration obligations in coordination with PIs and OGGA/RTO leadership/management to ensure timely and accurate study registration and results reporting.

Compliance, Audit, and Quality Assurance:

· Conducts routine quality assurance reviews of IRB records and study files to ensure audit readiness for FDA inspections, sponsor monitoring visits, NIH site visits, and internal compliance reviews.

· Supports preparation for pursuit of AAHRPP accreditation in FY28 by maintaining documentation and operational practices aligned with accreditation standards.

· Tracks and manages Multi-Site Research/Cooperative Agreement (MRCA) processes and IRB Reliance Agreement (Single IRB/sIRB) arrangements with academic or trial research partners.

· Assists the Director in developing and updating IRB policies, standard operating procedures (SOPs), and submission templates to align with regulatory changes and institutional needs.

Investigator Education and Outreach:

· Provides regulatory guidance and pre-submission consultations to Principal Investigators, research coordinators, fellows, and residents on IRB submission requirements to the Cayuse platform, human subjects protections, and Good Clinical Practice (GCP) (consulting with the RTO Manager).

· Delivers or coordinates IRB orientation sessions, researcher training workshops, and compliance monitoring to ensure all study personnel meet human subjects training requirements.

· Advises researchers on study design classification, appropriate use of waiver provisions, and community-engaged research considerations relevant to Sinai’s patient population.

· Collaborates with SUHI and or academic investigators on protocol submissions involving community-based participatory research, ensuring culturally appropriate consent and participant engagement practices.

Administrative Operations and Records Management:

· Maintains the IRB’s electronic (Cayuse cloud-based) protocol files, correspondence records, Board member rosters, and conflict-of-interest disclosures in compliance with federal record retention requirements (minimum 3 years post-study completion, or longer as applicable).

· Coordinates IRB Board member recruitment, orientation, and annual training with the IRB Chair and Director, OGGA.

· Supports eRA Commons Human Subjects submissions and Just-in-Time (JIT) requests for federally funded research requiring IRB approval as a grant condition.

· Assists in the evaluation and optimization of the IRB electronic submission platform (CAYUSE) to improve operational efficiency and data integrity.

· Investigates artificial intelligence models such as Co-Pilot, and with the approval of the director, OGGA, adopts/adapts their use to improve the IRB’s operations, processes, and outcomes.

· Performs other duties as assigned.

Education and Work Experience:

· Required: Bachelor’s degree in a health science, biological science, public health, nursing, social science, or related field

· Preferred: Master’s degree in public health, clinical research administration, health administration, or a relevant clinical or regulatory discipline

· Required: Minimum 1 year of experience in IRB administration, human subjects research compliance, or clinical research coordination

· Preferred: 2-4 years of experience in an IRB office at an academic medical center, safety-net hospital, or research institution with an active industry-sponsored clinical trials portfolio

· Experience with FDA-regulated IND and IDE trials (21 CFR Parts 312 and 814) preferred

· Experience supporting multi-site research, Single IRB (sIRB) reliance processes, or NIH-funded research programs is a plus

Knowledge and Skills:

· Working knowledge of 45 CFR 46 (Common Rule), 21 CFR Parts 50, 56, 312, and 814, HIPAA Privacy Rule (45 CFR 164), and ICH E6(R3) Good Clinical Practice guidelines

· Ability to interpret complex regulatory requirements, apply them to study-specific scenarios, and communicate guidance clearly to investigators and research staff with varying levels of research experience

· Strong organizational and project management skills, including the ability to manage high submission volumes, competing deadlines, and multiple concurrent Board cycles

· Proficiency with IRB electronic submission management systems, if not CAYUSE

· Experience with ClinicalTrials.gov desired

· Excellent written and oral communication skills, including the ability to draft clear regulatory correspondence, Board minutes, and policy documents

· Cultural competency and sensitivity to working with diverse patient populations and community-engaged research contexts consistent with Sinai’s mission

· Ability to work collaboratively across departments, including research, clinical, legal, compliance, and other functions where appropriate

· Experience in EPIC and MEDITECH software systems preferred.

Certifications/Licenses:

· Required: Human Subjects Protection training (current within 3 years);

· Preferred: GCP training for clinical trials personnel

· Desired: Certification in Clinical Research (e.g., CCRC, CRA) or enrollment in a clinical research compliance training program with 12 months assuming funding support

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