Director of Research Compliance

2 days ago

Miami Beach, United States Mount Sinai Medical Center of Florida Full time

Director of Research Compliance


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.


Culture of Caring: The Sinai Way

Our hardworking, tight-knit community of more than 4,000 dedicated employees fosters an environment of care and compassion. Each member plays a vital role in our collective mission to deliver excellent healthcare through innovation, education, and research. At Mount Sinai, we take pride in our achievements, aiming to be a beacon of quality healthcare in South Florida. We welcome all healthcare professionals to join our thriving community and contribute to our pursuit for clinical excellence.


Position Responsibilities:

  • Provides guidance to research investigators on the preparation of human research proposals, formulate and assist in the planning and preparation of such proposals in compliance with Federal regulations and MSMC policies.
  • Conducts preliminary reviews of protocols submitted by the residents and request revisions prior to the submission to the IRB Chairman for review.
  • Reviews all protocol submissions including new submissions, renewals, revisions, deviations.
  • Reviews and revise 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 IRB database.
  • Ensures that the IRB membership complies with federal regulations.
  • Acts as a liaison between Mount Sinai and external IRBs. Serves as an IRB or ARC representative during any audits conducted by OHRP, FDA, USDA, AAALAC, or any other regulatory agency.
  • 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. Assists investigators in the preparation of budgets for animal research proposals providing budgetary information (purchase of animals, per diems, etc.).
  • Ensures that semi-annual inspections are conducted as required by federal regulations
  • Outlines any deficiencies identified during the semi-annual inspection 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 Office for Human Research Protections (OHRP) incorporating IRB policies and procedures and federal guidelines as well as the Animal Welfare Assurance to the Office of Laboratory Animal Welfare (OLAW).
  • Updates the Federal-Wide Assurance and Institutional Review Board Registration with OHRP as required.
  • Prepares Animal Care Program Descriptions for AAALAC Accreditation.
  • Completes United States Department of Agriculture (USDA), Office of Laboratory Animal Welfare (OLAW) and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) annual reports.
  • Identifies and recommends policies and procedures for the IRB and ARC to assure the interpretation and implementation of the provisions of the FWA, General Welfare Assurance, FDA, USDA and AAALAC.
  • 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.
  • Conduct audits of research protocols when required.
  • Assists AVP in Research Administration with grant managements
  • Liaison with ERA Commons and Grants.gov, the site for NIH grant proposal submission and administration process.
  • Act as a liaison with SAM.gov Registration Services for Businesses to Contract and Nonprofits for Grants and with ERA Commons and Grants.gov.
  • Evaluates the job performance of clerical staff in the Office of Research Administration. With AVP in Research Administration, mediates individual employee concerns relating to disciplinary counseling sessions and other actions regarding assigned staff.
  • Assure that PPA forms are submitted for employee positions funded by grants/contracts.
  • Other duties as assigned.

Qualifications:

  • CIP certified (Certified IRB Professional). CPIA Certification preferable but not required.
  • Bachelors degree required. Masters Degree preferred.
  • Five years of qualifying relevant IRB experience.


Benefits

We believe in the physical and mental well-being of our employees and are committed to offering comprehensive benefits that fit their personal needs. Our robust employee benefits package includes:

  • Health benefits
  • Life insurance
  • Long-term disability coverage
  • Healthcare spending accounts
  • Retirement plan
  • Paid time off
  • Pet Insurance
  • Tuition reimbursement
  • Employee assistance program
  • Wellness program
  • On-site housing for select positions and more

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