Regulatory Compliance Coordinator I - Medicine Clinical Trials Office

Mount Sinai Health System • New York, NY

402d

About The Position

The Regulatory Compliance Coordinator I will support the Medicine Clinical Trials Office (MCTO) by managing electronic systems crucial for MCTO operations. This role focuses on ensuring compliance with FDA regulations, ICH-GCP guidelines, and other relevant regulations for clinical trials. The coordinator will maintain the electronic Trial Master File (eTMF) and work closely with cross-functional teams to ensure regulatory documentation is accurate and submitted timely, contributing to the integrity and success of clinical trials.

Requirements

• Bachelor degree preferred, or equivalent combination of education and applicable experience (preferred: research or regulatory)
• 3 years of experience in clinical research or a related field; experience in clinical trials management is preferred
• Ability to read research protocols and 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 MS Word and Excel
• Experience with FDA, EMA or other global health authority submissions is an asset

Nice To Haves

• MS degree or advanced certification in regulatory affairs or clinical research is preferred

Responsibilities

• Assist in the planning, coordination and execution of regulatory projects
• Maintain electronic database systems and spreadsheets to facilitate tracking and documentation of departmental activities
• Investigate and organize utilization of 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 signatures pages and FDA 1572 Forms to obtain local investigator signatures
• Ensure all necessary regulatory documents are submitted to Sponsor company to activate protocols
• Ensure timely submission of trial-related documents to regulatory authorities
• Prepare, maintain, update and audit study specific regulatory files, IRB files and location profile filing system per FDA guidelines and resolve queries as necessary
• 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 in the eTMF system
• Ensure proper indexing and classification of documents with the eTMF
• Conduct regular audits of the eTMF to identify and resolve discrepancies or missing documents
• Prepare for internal and external audits, ensuring that the necessary documentation and records are readily available for inspection
• Train and support team members on the use of the eTMF systems
• Participate in internal and external audits and inspections as needed
• Verbally communicate effectively with the company's coordinators, staff and management; pharmaceutical companies; IRBs and other team members
• Collaborate with cross-functional teams to resolve regulatory issues and facilitate project progression
• Communicate effectively when reading and writing emails.

What This Job Offers

• Job Type: Full-time
• Industry: Hospitals
• Education Level: Bachelor's degree