Regulatory Research Coordinator

Mount Sinai Medical Center; Miami Beach (FL); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Long-term disability

Tuition reimbursement

Paid time off

Retirement plan

Employee assistance program

Wellness program

Job summary

Mount Sinai Medical Center in Miami Beach, FL, seeks a regulatory professional to support cancer clinical research protocols and IRB submissions. The role involves preparing regulatory packages, coordinating site activations, and ensuring compliance with IRB and sponsor guidelines.

The position includes supporting NCI and FDA audits, maintaining regulatory files, and assisting physicians and staff with regulatory requirements. A Bachelor’s degree is preferred and regulatory experience is valued.

Qualifications

• Regulatory experience preferred.
• Bachelor's degree preferred.

Responsibilities

• Facilitates opening of cancer clinical research protocols.
• Prepares forms and informed consents for submission to MSMC IRB.
• Prepares regulatory packages for study sponsors.
• Organizes study initiations at MSMC and MS-Aventura.
• Coordinates monitoring visits by study sponsors at MSMC and MS-Aventura.
• Assists clinical staff in answering queries from study sponsors.
• Creates regulatory and protocol files for cancer studies.
• Keeps regulatory binders/files organized and updated.
• Submits study amendments, revisions, and updates to the IRB.
• Coordinates distribution of activated protocols and protocol consent changes to sites.
• Submits annual reviews for cancer studies to IRB.
• Reports adverse events to appropriate entities per IRB and sponsor guidelines.
• Assists with preparation for NCI and FDA audits.
• Sets up tracking log of all submitted/approved IRB documents.

Education

Bachelor's Degree preferred

Job description

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.

Department:

Job Description Summary:

Position Responsibilities

• Facilitates the opening of cancer clinical research protocols.
• Prepares forms and informed consents for submission to MSMC Institutional Review Board.
• Prepares regulatory packages for the study sponsors.
• Organizes study initiations at MSMC and MS-Aventura.
• Coordinates monitoring visits by study sponsors at MSMC and MS-Aventura.
• Assists clinical staff in answering queries from study sponsors.
• Creates regulatory and protocol files for cancer studies.
• Keeps all regulatory binders/files organized and updated.
• Submits study amendments, revisions, and updates as needed to the IRB.
• Coordinates the distribution of newly activated protocols and protocol consent changes/updates to appropriate sites.
• Submits annual reviews for cancer studies to IRB.
• Reports adverse events to appropriate entities according to IRB and study sponsor guidelines.
• Assists with preparation for NCI and FDA audits.
• Sets up and maintain a tracking log of all submitted/approved IRB documents.
• Performs ad hoc duties for physician participation in NCI studies.
• Prepares submissions to the FDA for IND status.
• Assists Coordinator of Quality Assurance and Data Management in preparing protocol version and consent tracking documents.
• Acts as resource for research staff and physicians with regard to regulatory requirements.
• Coordinates activities of study sponsors with physicians and clinical research staff as needed.
• Performs all assigned tasks including clerical duties (answering telephones, typing, ordering supplies) to assist clinical staff,when required.
• Assists physicians in manuscript preparation, as required.

Qualifications

License/Registration/Certification

• Not applicable

Education

• Bachelors Degree preferred

Experience

• Regulatory experience preferred

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:

• 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!

Degree Requirements:

Certification: