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REGULATORY COMPLIANCE COORDINATOR I - DERMATOLOGY
Ground breaking science. Advancing medicine. Healing made personal.
Roles & Responsibilities:
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.
- 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.
- Bachelors degree preferred, or an equivalent combination of education and applicable experience (preferred: experience in a health care research or regulatory environment)
- 3 years of experience in clinical research or a related field
- Experience working with sponsors, FDA and consortiums preferred.
- Requires good written and verbal communication skills.
- Ability to work with a variety of faculty and staff as well as outside agencies.
The Mount Sinai Health System
believes that diversity is a driver for excellence. We share a common devotion
to delivering exceptional patient care. Yet we’re as diverse as the city we
call home- culturally, ethically, in outlook and lifestyle. When you join us,
you become a
part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize medicine together.
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.