Research Program Coordinator Medicine Clinical Trials Office
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Job Location:
New York City, NY - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
This individual will report directly to the Medicine Clinical Trials Office (MCTO) Research Manager to assist with management of the electronic systems most important to MCTO operations. The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects.
This role includes maintaining the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements. The coordinator will work closely with cross-functional teams to ensure that regulatory documentation is accurate complete and submitted in a timely manner. The Regulatory Coordinator is responsible for ensuring regulatory compliance across U.S. and international research sites. This role supports the coordination submission and maintenance of regulatory documentation in accordance with institutional federal and international guidelines. The coordinator will work closely with site teams sponsors and regulatory authorities to facilitate timely approvals and ongoing compliance. Additional duties include operational assistance with other essential systems as well as a variety of special projects; once an understanding of the general duties listed below has been acquired this individual will coordinate efforts to achieve the performance improvement and systems integration goals of the MCTO.
Responsibilities
Regulatory Oversight & Documentation
- Coordinate regulatory activities for multi-site clinical trials including domestic and international locations.
- Prepare review and submit regulatory documents (e.g. IRB/IEC submissions informed consent forms site-specific
regulatory packets). - Collect organize and assemble regulatory submissions including FDA 1572 Forms financial disclosure forms and
protocol signature pages. - Ensure all required regulatory documents are submitted to sponsors to activate protocols.
- Distribute IRB documentation to sponsors research and clinical staff.
- Maintain accurate records of all regulatory submissions and correspondence.
- Prepare update and audit study-specific regulatory files IRB files and location profile systems in accordance with
FDA guidelines. - Participate in internal and external audits and inspections as needed.
Systems & Data Management
- Maintain electronic database systems and spreadsheets to track and document departmental activities.
- Manage the electronic Trial Master File (eTMF) to ensure it is complete current and compliant with regulatory
standards. - Organize scan upload and properly index documents within the eTMF system.
- Conduct regular audits of the eTMF to identify and resolve discrepancies or missing documents.
- Investigate and implement system integrations/interfaces to improve workflow and data accuracy.
Project Coordination & Reporting
- Assist in the planning coordination and execution of regulatory projects.
- Track and manage regulatory timelines to ensure timely submissions and approvals.
- Collaborate with research regulatory and finance teams to meet project goals and deadlines.
- Provide regular updates on project status issues and progress to senior management.
- Provide ad hoc reporting to MCTO leadership as needed.
Training & Team Support
- Train and support team members on the use of regulatory systems including the eTMF.
- Assist MCTO in developing systems learning tools for staff.
Communication & Collaboration - Serve as a liaison between internal teams and external stakeholders to resolve regulatory issues and facilitate
project progression. - Communicate effectively in verbal and written formats with coordinators staff management pharmaceutical
companies IRBs and other stakeholders. - Demonstrate strong teamwork attention to detail organizational and planning skills.
- Prioritize tasks effectively in a multi-task environment.
Qualifications
- Masters degree in Natural Sciences OR Bachelors degree in Natural Sciences plus 5 years of progressive research experience with some experience in research administration preferred.
- 4 years of research experience (5 years if no Masters degree) in data management and study coordination in healthcare or basic research.
Required Experience:
IC
Key Skills
- Project / Program Management
- Program Management
- Developmental Disabilities Experience
- Organizational skills
- Data Collection
- Meeting Facilitation
- Utilization Review
- Administrative Experience
- Program Development
- Public Speaking
- Supervising Experience
- Social Work
About Company
Strength through Unity and Inclusion The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled ... View more
