Regulatory Research Coordinator

CMP01 Mount Sinai Medical Center of Florida, Inc.; United States; On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Long-term disability coverage

Retirement plan

Paid time off

Tuition reimbursement

Employee assistance program

Wellness program

On-site housing for select positions

Job summary

Mount Sinai Medical Center of Florida, Inc. seeks a Regulatory Affairs professional to open cancer clinical research protocols, prepare informed consent forms for IRB submission, and coordinate sponsor monitoring visits at MSMC and MS-Aventura.

You will maintain regulatory binders, submit amendments and protocol updates, and support audits while collaborating with physicians and study teams. A bachelor’s degree is preferred, and regulatory experience is welcomed.

Qualifications

• Regulatory experience preferred
• Bachelor's degree preferred
• Licensure not required

Responsibilities

• Facilitates the opening of cancer clinical research protocols.
• Prepares forms and informed consents for submission to MSMC IRB.
• Coordinates monitoring visits by study sponsors at MSMC and MS-Aventura.
• Submits study amendments, revisions, and updates to the IRB.
• Keeps regulatory binders/files organized and updated.
• Coordinates activities of study sponsors with physicians and clinical research staff.
• Performs ad hoc duties for physician participation in NCI studies.

Skills

Regulatory experience

Education

Bachelor's Degree

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

• 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:

More than 4,000 people work at Mount Sinai Medical Center at more than a dozen locations throughout sunny South Florida, including our flagship, 672-bed hospital on Biscayne Bay at the gateway to Miami Beach. We’re the largest, independent, not-for-profit hospital in South Florida, and we’re the only hospital Healthgrades recognized for four years running as one of the top 5% in the nation. Clearly, clinical excellence is at our core.