Regulatory Research 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

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 WayOur 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 ResponsibilitiesFacilitates 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.QualificationsLicense/Registration/CertificationNot applicableEducationBachelors Degree preferredExperienceRegulatory experience preferredBenefits: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 benefitsLife insuranceLong-term disability coverageHealthcare spending accountsRetirement planPaid time offPet InsuranceTuition reimbursementEmployee assistance programWellness programOn-site housing for select positions and more!Degree Requirements:Certification: