Easter Seals Jobs

Job Description

This individual will report directly to the Medicine Clinical Trials Office (MCTO Research Manager to assist with the management of the electronic systems most important to MCTO operations. The Regulatory Coordinator will be responsible for supporting the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and other relevant local and international regulations for clinical trials and studies. 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. The position is vital for ensuring the integrity of clinical trials, maintaining regulatory compliance and contributing to the overall success of research initiatives.

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.

Qualifications

• Bachelor degree preferred, or equivalent combination of education and applicable experience (preferred: research or regulatory); MS degree or advanced certification in regulatory affairs or clinical research is preferred

• 3 years of experience in clinical research or a related field; experience in clinical trials management is preferred

• Ability to read research protocols and 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 MS Word and Excel

• Experience with FDA, EMA or other global health authority submissions is an asset

Responsibilities

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

• Maintain electronic 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

• Distribute and track financial disclosure forms, protocol signatures pages and FDA 1572 Forms to obtain local investigator signatures

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

• Ensure timely submission of trial-related documents to regulatory authorities

• Prepare, maintain, update and audit study specific regulatory files, IRB files and location profile filing system per FDA guidelines and resolve queries as necessary

• Distribute 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 in the eTMF system

• Ensure proper indexing and classification of documents with the eTMF

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

• Prepare for internal and external audits, ensuring that the necessary documentation and records are readily available for inspection

• Train and support team members on the use of the eTMF systems

• Participate in internal and external audits and inspections as needed

• Verbally communicates effectively with the 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

• Communicate effectively when reading and writing email, letters and other reports

• Provide ad hoc reporting to 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

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

Compensation Statement

Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $58661 - $67500 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.