Director of Research Compliance

Mount Sinai Health System - Miami Beach, FL

Full-time - Director

Miami Beach, FL

1,001-5,000 employees

Hospitals

About the position

As Mount Sinai grows, so does our legacy in high-quality health care. Since 1949, Mount Sinai Medical Center has remained committed to providing access to its diverse community. In delivering an unmatched level of clinical expertise, our medical center is committed to recruiting and training top healthcare workers from across the country. We offer the latest in advanced medicine, technology, and comfort in 12 facilities across Miami-Dade (including our 674-bed main campus facility) and Monroe Counties, with 38 medical services, including cancer care, 24/7 emergency care, orthopedics, cardiovascular care, and more. Mount Sinai takes pride in being South Florida's largest private independent not-for-profit hospital, dedicated to continuing the training of the next generation of medical pioneers. The Director of Research Compliance plays a crucial role in ensuring that all research activities comply with federal regulations and institutional policies. This position provides guidance to research investigators on the preparation of human research proposals, formulates and assists in the planning and preparation of such proposals in compliance with Federal regulations and MSMC policies. The Director conducts preliminary reviews of protocols submitted by residents and requests revisions prior to submission to the IRB Chairman for review. This role also involves reviewing all protocol submissions, including new submissions, renewals, revisions, and deviations, as well as revising all informed consent forms submitted prior to review by the IRB. In addition to overseeing the IRB database and ensuring compliance with federal regulations, the Director acts as a liaison between Mount Sinai and external IRBs. The position also requires serving as an IRB or ARC representative during audits conducted by regulatory agencies. The Director is responsible for assisting investigators in budget preparation for animal research proposals, ensuring semi-annual inspections are conducted, and preparing and maintaining the Institution's Federal-Wide Assurance with DHHS Office for Human Research Protections (OHRP). This role also includes developing and maintaining the IRB/ARC Policies and Procedures Manual and attending national conferences to stay updated on federal guidelines in research.

Responsibilities

• Provides guidance to research investigators on the preparation of human research proposals.
• Conducts preliminary reviews of protocols submitted by residents and requests revisions prior to submission to the IRB Chairman.
• Reviews all protocol submissions including new submissions, renewals, revisions, and deviations.
• Reviews and revises all informed consent forms submitted prior to review by the IRB.
• Conducts educational sessions for house staff and investigators on research policies and procedures.
• Oversees the IRB database and ensures compliance with federal regulations.
• Acts as a liaison between Mount Sinai and external IRBs.
• Serves as an IRB or ARC representative during audits conducted by regulatory agencies.
• Assists investigators in the preparation of budgets for animal research proposals.
• Ensures that semi-annual inspections are conducted as required by federal regulations.
• Outlines deficiencies identified during semi-annual inspections to the Institutional Official.
• Sends correspondence to investigators indicating the action taken on their ARC submissions.
• Supervises the Animal Invoicing for the Research Facility.
• Tracks all animal orders to assure compliance with approved protocols.
• Prepares and maintains the Institution's Federal-Wide Assurance with DHHS OHRP.
• Updates the Federal-Wide Assurance and IRB Registration with OHRP as required.
• Prepares Animal Care Program Descriptions for AAALAC Accreditation.
• Completes USDA, OLAW, and AAALAC annual reports.
• Identifies and recommends policies and procedures for the IRB and ARC.
• Submits Possible Misconduct in Research reports to the Office of Research Integrity annually.
• Develops and maintains the IRB/ARC Policies and Procedures Manual.
• Attends national conferences to obtain knowledge of federal guidelines in research.
• Creates and maintains policies in PolyStat.
• Conducts audits of research protocols when required.
• Assists AVP in Research Administration with grant management.
• Acts as a liaison with SAM.gov Registration Services for Businesses to Contract and Nonprofits for Grants.
• Evaluates the job performance of clerical staff in the Office of Research Administration.
• Mediates individual employee concerns relating to disciplinary counseling sessions and other actions regarding assigned staff.
• Assures that PPA forms are submitted for employee positions funded by grants/contracts.

Requirements

• CIP certified (Certified IRB Professional) or CPIA Certification preferable but not required.
• Bachelor's degree required.
• Master's Degree preferred.
• Five years of qualifying relevant IRB experience.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Pet Insurance
• Tuition reimbursement
• Wellness program
• On-site housing for select positions