Mount Sinai Morningside
Regulatory Compliance Coordinator I - Cardiology
Mount Sinai Morningside, New York, New York, us, 10261
Regulatory Compliance Coordinator I - Cardiology
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Regulatory Compliance Coordinator I - Cardiology
role at
Mount Sinai Morningside .
Description
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.
Responsibilities
Work with investigators to create new protocols, informed consent forms, case report forms, and additional study documents as needed per protocol.
Track new protocols through the committee system to approval and respond to committees’ inquiries.
Gather data needed to prepare and process applications for IRB review and approval.
Collaborate with the Principal Investigator (PI) in completing application documents, including all required PPHS paperwork, for approval of new clinical research trials.
Coordinate conference calls with investigators to aid in study development.
Obtain IND# for the clinical trials through correspondence with the FDA and submission of paperwork necessary to obtain an IND#.
Collaborate with the Financial Manager on the development of the study budget (as needed); identify billable versus research non‑billable tests for the budget.
Update and maintain records of protocols on clinicaltrials.gov.
Communicate protocol approvals and distribute all applications to investigators and other departments.
Upon protocol approval, transition the protocol to be implemented by investigators, program managers, clinical research coordinators, regulatory coordinators, and research nurses.
Organize and conduct start‑up meetings for new protocols.
Perform related duties as assigned or requested.
Qualifications
Bachelor’s 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.
Employer Description
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. It is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees across eight hospitals, over 400 outpatient practices, and more than 300 labs. Mount Sinai advances health for all people by developing safer, more effective treatments, educating the next generation of medical leaders, and supporting local communities with high‑quality care. The Health System includes more than 9,000 primary and specialty care physicians, 13 joint‑venture outpatient surgery centers throughout New York, Westchester, Long Island, and Florida, and more than 30 affiliated community health centers.
Equal Opportunity Employer
Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. The institution does not discriminate based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other protected characteristic.
Compensation
Salary range: $64,526.72 – $67,500 annually. Actual salaries depend on experience, education, and operational need. The range does not include bonuses, incentive pay, differential pay, or other benefits.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Legal
Industries
Hospitals and Health Care
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Regulatory Compliance Coordinator I - Cardiology
role at
Mount Sinai Morningside .
Description
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.
Responsibilities
Work with investigators to create new protocols, informed consent forms, case report forms, and additional study documents as needed per protocol.
Track new protocols through the committee system to approval and respond to committees’ inquiries.
Gather data needed to prepare and process applications for IRB review and approval.
Collaborate with the Principal Investigator (PI) in completing application documents, including all required PPHS paperwork, for approval of new clinical research trials.
Coordinate conference calls with investigators to aid in study development.
Obtain IND# for the clinical trials through correspondence with the FDA and submission of paperwork necessary to obtain an IND#.
Collaborate with the Financial Manager on the development of the study budget (as needed); identify billable versus research non‑billable tests for the budget.
Update and maintain records of protocols on clinicaltrials.gov.
Communicate protocol approvals and distribute all applications to investigators and other departments.
Upon protocol approval, transition the protocol to be implemented by investigators, program managers, clinical research coordinators, regulatory coordinators, and research nurses.
Organize and conduct start‑up meetings for new protocols.
Perform related duties as assigned or requested.
Qualifications
Bachelor’s 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.
Employer Description
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. It is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees across eight hospitals, over 400 outpatient practices, and more than 300 labs. Mount Sinai advances health for all people by developing safer, more effective treatments, educating the next generation of medical leaders, and supporting local communities with high‑quality care. The Health System includes more than 9,000 primary and specialty care physicians, 13 joint‑venture outpatient surgery centers throughout New York, Westchester, Long Island, and Florida, and more than 30 affiliated community health centers.
Equal Opportunity Employer
Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. The institution does not discriminate based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other protected characteristic.
Compensation
Salary range: $64,526.72 – $67,500 annually. Actual salaries depend on experience, education, and operational need. The range does not include bonuses, incentive pay, differential pay, or other benefits.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Legal
Industries
Hospitals and Health Care
#J-18808-Ljbffr