Research Program Coordinator

4 weeks ago

New York, New York, United States Mount Sinai Hospital Full time
Job Summary

The Mount Sinai Health System is seeking a highly skilled Research Program Coordinator to join our team. As a key member of our research team, you will be responsible for supporting the management of electronic systems critical to our operations. This role involves coordinating regulatory projects, maintaining electronic databases, and ensuring compliance with regulatory requirements. If you have a strong background in research administration and a passion for regulatory affairs, we encourage you to apply.

Key Responsibilities
  • Assist in the planning, coordination, and execution of regulatory projects
  • Maintain electronic database systems and spreadsheets to track departmental activities
  • Investigate and organize system integrations/interfaces
  • Collaborate with research, regulatory, and finance teams to ensure overall completion of goals and deadlines
  • Collect, review, organize, and assemble regulatory submissions
  • Distribute and track financial disclosure forms, protocol signature pages, and FDA 1572 Forms
  • Ensure all necessary regulatory documents are submitted to Sponsor companies to activate protocols
  • Prepare, maintain, update, and audit study-specific regulatory files, IRB files, and location profile filing systems per FDA guidelines
  • Distribute IRB documentation to study sponsors, research, and clinical staff
  • Maintain accurate records of all regulatory submissions and correspondence
  • Maintain and manage the electronic Trial Master File (eTMF) to ensure it is up-to-date, complete, and compliant with regulatory standards
  • Organize, scan, and upload regulatory documents into the eTMF system
  • Ensure proper indexing and classification of documents within the eTMF
  • Conduct regular audits of the eTMF to identify and resolve discrepancies or missing documents
  • Train and support team members on the use of the eTMF system
  • Participate in internal and external audits and inspections as needed

Requirements
  • 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
  • Experience in clinical research study or trial management preferred
  • Ability to read research protocols to synthesize information
  • Creative problem-solving skills; ability to navigate through ambiguous situations
  • Proven organizational skills including attention to detail and multi-tasking skills
  • Proficient with Microsoft Word, Excel
  • Training in GCP and HIPAA regulations will be required

About Us

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai's unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:
  • Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
  • Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.
  • Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

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