JOB DESCRIPTION

This position will report directly to the Medicine Clinical Trials Office (MCTO) Research Manager to assist with management of the electronic systems most important to MCTO operations. The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects. This role includes maintaining the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements. The coordinator will work closely with cross-functional teams to ensure that regulatory documentation is accurate, complete, and submitted in a timely manner.

Additional duties include operational assistance with other essential systems , as well as a variety of special projects; once an understanding of the general duties listed below has been acquired, this individual will coordinate efforts to achieve the performance improvement and systems integration goals of the MCTO.

RESPONSIBILITIES

• Assist in the planning, coordination, and execution of regulatory projects

• Maintain electronics database systems and spreadsheets as necessary to facilitate tracking and documentation of departmental activities;

• Investigate and organize utilization of system integrations/interfaces

• Collaborate with research, regulatory, and finance teams to ensure overall completion of goals and deadlines

• Collect, review, organize, and assemble regulatory submissions;

• Distributes and tracks financial disclosure forms, protocol signature pages and FDA 1572 Forms to obtain local investigator signatures.

• Ensures all necessary regulatory documents are submitted to Sponsor company to activate protocols.

• Prepares, maintains, updates and audits study specific regulatory files, IRB files and location profile filing system per FDA guidelines and resolves queries as necessary.

• Distributes IRB documentation to study sponsors, research and clinical staff.

• Maintain accurate records of all regulatory submissions and correspondence.

• Maintain and manage the electronic Trial Master File (eTMF) to ensure it is up-to-date, complete, and compliant with regulatory standards.

• Organize, scan, and upload regulatory documents into the eTMF system.

• Ensure proper indexing and classification of documents within the eTMF.

• Conduct regular audits of the eTMF to identify and resolve discrepancies or missing documents.

• Train and support team members on the use of the eTMF system.

• Participate in internal and external audits and inspections as needed.

• Ability to verbally communicate effectively with company’s coordinators, staff and management; pharmaceutical companies; IRBs; and other team members.

• Collaborate with cross-functional teams to resolve regulatory issues and facilitate project progression

• Ability to communicate effectively when reading and writing e-mail, letters and other reports.

• Strong focus on teamwork, attention to detail, excellent organizational and planning skills.

• Must have ability to prioritize, excellent communication skills, and ability to work in a multi-task environment.

• Provide ad hoc reporting to the MCTO leadership, as necessary

• Provide regular updates on project status, potential issues, and progress to senior management.

• Assist the MCTO in developing systems learning tools for MCTO staff

• Complete special projects as assigned

QUALIFICATIONS

• Masters degree in Natural Sciences OR Bachelors degree in Natural Sciences plus 5 years of progressive research experience with some experience in research administration preferred

• 4 years of research experience (5 years if no Masters degree) in data management and study coordination in healthcare or basic research.

• Experience in clinical research study or trial management preferred

• Ability to read research protocols to synthesize information

• Creative problem solving skills; ability to navigate through ambiguous situations

• Proven organizational skills including attention to detail and multi-tasking skills

• Proficient with Microsoft Word, Excel

• Training in GCP and HIPAA regulations will be required.

REQUIRED SKILLS

MS Excel

MS Word

Microsoft Access

Outlook

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 : 3016134