Description
**JOB DESCRIPTION**
As the Clinical Trials Manager, you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated studies, and/or those from pharmaceutical companies. The manager will instruct and trains staff regarding the requirements for all protocols; provides support for ongoing research projects and provides 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.
Assist with the coordination of the MPD Consortium, a NCI-sponsored program of 35 institutions in the United States and Europe, of which Mount Sinai is the lead site. The consortium focuses on understanding the biological foundations of the myeloproliferative neoplasms and using that understanding to develop hypothesis-generated therapeutic trials to improve the therapy of patients.
Assist Investigator(s) with developing IITs multi-institutional consortium set up to coordinate, facilitate, and perform basic and clinical research.
Support the logical operations of the liquid tumor tissue bank(s).
Performs other related duties, as appropriate.
**QUALIFICATIONS**
Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred
6+ years of experience managing clinical trials, including 2 years in a management/leadership role
Excellent written, oral and interpersonal skills
Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance
Proven ability to provide scientific and clinical expertise in all phases of clinical trials
Excellent analytical and problem solving skills
Strong management and leadership skills
**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 B
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