Regulatory Affairs Coordinator — Cancer Trials

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

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.