JOB 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

1. Protocol development: Work with investigators to create new protocols, informed consent forms, case report forms, and additional study documents, as needed per protocol.

2. Tracks new protocols through the committee system to approval, responds to committees' inquiries.

3. Gathers data needed to prepare and process applications for IRB review and approval.

4. Collaborates with the Principal Investigator (PI) in completion of application documents including all required PPHS paperwork, for approval of new clinical research trials.

5. Coordinates conference calls with investigators to aid in study development.

6. Obtains IND# for the clinical trials through correspondence with the FDA, and submission of paperwork necessary to obtain an IND#.

7. Collaborates with the Financial Manager on the development of the study budget (as needed); identifies billable versus research non-billable tests for the budget.

8. Updates and maintains records of protocols on clinicaltrials.gov website.

9. Coordinates the communication of protocol sites, including: protocol approvals, and the distribution of all applications to investigators, and other departments.

10. 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).

11. Organizes and conducts start-up meetings for new protocols.

12. Performs related duties as assigned or requested.

QUALIFICATIONS

• 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.

REQUIRED SKILLS

Microsoft Office Suite

ABOUT US

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. 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 invite you to participate actively as a part of the Mount Sinai Health System team by:

• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.

• Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.

• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.

Explore more about this opportunity and how you can help us write a new chapter in our history!

“About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 14 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism.”

EOE Minorities/Women/Disabled/Veterans

Requisition ID : 3017394