Mount Sinai Morningside ยท 3 weeks ago
Regulatory Compliance Coordinator I - Cardiology
New York, NY
Full-time
Onsite
Entry Level
$65K/yr - $68K/yr
3+ years expMount Sinai Morningside is a part of the Mount Sinai Health System, committed to delivering outstanding patient care. The Regulatory Compliance Coordinator I will work with investigators and the Clinical Trials Office to develop new clinical trials, acting as the main contact during protocol development and coordinating start-up meetings for new protocols.
Hospital & Health Care
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
Qualification
Required
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 working with sponsors, FDA and consortiums preferred
Company
Mount Sinai Morningside
At Mount Sinai Morningside, we offer exceptional clinical care and research within the comfort of a neighborhood hospital known for compassion and sensitivity.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Faye Reiff-Pasarew
Deputy CMO, Associate Chief of Hospital Medicine, Assistant Professor of Internal Medicine
Lucy Xenophon, MD, MPH
Chief Transformation Officer
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