Apply on Employer Site

Mount Sinai Health System · 19 hours ago

Regulatory Compliance Coordinator I - Cardiology

New York, NY

Full-time

Onsite

Entry Level

$65K/yr - $68K/yr

3+ years exp

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, and they are seeking a Regulatory Compliance Coordinator I to work with investigators and assist in developing new clinical trials. The role involves protocol development, coordinating with committees, and managing communication related to clinical research protocols.

Health CareHospitalMedical

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