Cancer Clinical Research Regulatory Coordinator

Mount Sinai Medical Center; Miami Beach (FL); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Long-term disability

Retirement plan

Paid time off

Tuition reimbursement

Employee assistance program

Wellness program

On-site housing (select roles)

Job summary

Mount Sinai Medical Center in Miami Beach, FL is seeking a Regulatory Affairs professional to support cancer research initiatives. You will prepare forms and informed consents, compile regulatory packages, and organize study initiations across MSMC campuses, collaborating with physicians and study sponsors.

You will coordinate IRB submissions, monitor adverse events, assist with FDA IND submissions, and help ensure readiness for NCI and FDA audits.

Qualifications

• Bachelor's degree preferred for this role.
• Regulatory experience preferred in clinical research.
• Familiarity with IRB processes and regulatory submissions.

Responsibilities

• Facilitates opening of cancer clinical research protocols.
• Prepares forms and informed consents for IRB submission.
• Assembles regulatory packages for study sponsors.
• Coordinates study initiations at MSMC and MS-Aventura.
• Monitors visits by study sponsors at MSMC and MS-Aventura.
• Answers sponsor queries and maintains regulatory files.
• Submits amendments and updates to IRB; coordinates protocol changes.
• Assists with FDA IND submissions and audits readiness.
• Supports QA/Data Management in protocol/tracking documents.
• Performs clerical duties to support clinical staff as needed.

Skills

Regulatory knowledge

IRB coordination

Study coordination

Regulatory filings

Manuscript preparation

Education

Bachelor's degree

Job description

Mount Sinai Medical Center in Miami Beach, FL is seeking a Regulatory Affairs professional to support cancer research initiatives. You will prepare forms and informed consents, compile regulatory packages, and organize study initiations across MSMC campuses, collaborating with physicians and study sponsors.

You will coordinate IRB submissions, monitor adverse events, assist with FDA IND submissions, and help ensure readiness for NCI and FDA audits.