Regulatory Compliance Coordinator I - Cardiology

Mount Sinai Health System • New York, NY

4d

About The Position

The Regulatory Compliance Coordinator I works with investigators, consortiums, and the Clinical Trials Office infrastructure to develop new clinical trials. The individual will be expected to act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols.

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

Nice To Haves

• Experience working with sponsors, FDA and consortiums preferred.

Responsibilities

• Protocol development: Work with investigators to create new protocols, informed consent forms, case report forms, and additional study documents, as needed per protocol.
• Tracks new protocols through the committee system to approval, responds to committees' inquiries.
• Gathers data needed to prepare and process applications for IRB review and approval.
• Collaborates with the Principal Investigator (PI) in completion of application documents including all required PPHS paperwork, for approval of new clinical research trials.
• Coordinates conference calls with investigators to aid in study development.
• Obtains IND# for the clinical trials through correspondence with the FDA, and submission of paperwork necessary to obtain an IND#.
• Collaborates with the Financial Manager on the development of the study budget (as needed); identifies billable versus research non-billable tests for the budget.
• Updates and maintains records of protocols on clinicaltrials.gov website.
• Coordinates the communication of protocol sites, including: protocol approvals, and the distribution of all applications to investigators, and other departments.
• Upon protocol approval, transitions the protocol to be implemented by investigator(s), program manager(s), clinical research coordinator(s), regulatory coordinator(s), and research nurse(s).
• Organizes and conducts start-up meetings for new protocols.
• Performs related duties as assigned or requested.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees