Clinical Trials Manager
3 weeks ago
As a Clinical Trials Manager at Mount Sinai Health System, you will play a critical role in coordinating and managing multiple clinical trial projects and protocols. This includes federally funded studies, investigator-initiated studies, and those from pharmaceutical companies.
The manager will instruct and train staff regarding the requirements for all protocols, provide support for ongoing research projects, and offer administrative oversight and guidance regarding staff roles and regulatory submissions for each study.
This position reports into the Executive Director of Clinical Research Administration within the Tisch Cancer Institute.
Responsibilities- Manages and coordinates clinical trial and related research studies conducted by the principal investigator(s) to ensure conformance with specified research objectives and protocols.
- Coordinates and establishes clinical trial schedules, task assignments, and allocation of staff.
- Oversees the status of all subjects enrolled in clinical trials, including completion and tracking of all required regulatory documents, including the appropriate reporting of all SAEs.
- Ensures clinical research studies are conducted according to good clinical practices, specified research protocols, and requirements of the Icahn School of Medicine at Mount Sinai, outside sponsors, and all federal and/or state regulatory agencies.
- Serves as the primary liaison with pharmaceutical companies for industry-sponsored clinical trials.
- Provides updates on status, adverse side effects, and trends, evaluates patient enrollment, and provides appropriate recommendations and/or conclusions.
- May play a role in monitoring and reconciling budget and other financial items for clinical trials and tracking reimbursements from sponsoring parties.
- Develops policies and procedures for administrative oversight of clinical trials; conducts regular meetings with staff to ensure compliance with established practices and to keep employees abreast of current standards and policies.
- Organizes grant submissions and implements standard operating procedures for clinical monitoring.
- Manages and monitors all sites involved in multi-site clinical trials which the principal investigator is responsible for, including recruitment and management of subject enrollment.
- Assists with various personnel functions such as hiring, performance appraisals, coaching, disciplinary actions, and terminations.
- Provides guidance and support to staff and orients and mentors new research team members.
About the Mount Sinai Health System
Mt 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.
Mt 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.
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 in various specialties.
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