Clinical Trials Manager - Center for Interventional Cardiovascular Research and Clinical Trials

The Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This individual instructs staff regarding appropriate protocols; provides support for ongoing research projects and provides administrative oversight regarding staff roles and instructions for each study.

Responsibilities

1.Manages and coordinates assigned clinical trial research studiesconducted by a principal investigator to ensure conformance with specifiedresearch objectives and protocols.

2.Coordinates and establishes clinical trials schedules, task assignmentsand allocation of staff and equipment.

3.Coordinates and manages all subjects enrolled in clinical trials,including completion and tracking of all required regulatory documents.

4.Ensures clinical research studies are conducted according to regulatoryrequirements, good clinical practices and specified research protocols,including Mount Sinai School of Medicine, outside sponsors and federal and/orstate regulatory agencies.

5.Serves as the primary liaison for clinical trials conducted forpharmaceutical companies. Provides status reports, adverse side effects andtrends, evaluates patient enrollment and provides appropriate recommendationsand/or conclusions.

6.May monitor and reconcile budget and other financial items for clinicaltrials; tracks reimbursements from the sponsoring agency (ies).

7.Develops policies and procedures for clinical trials; conducts meetingswith staff to ensure compliance with established practices and to keepemployees abreast of current changes and standards.

8.Organizes grant submissions and implements standard operating proceduresfor clinical monitoring. Manages and monitors sites involved in clinicaltrials including the recruitment and management of subjects.

9.Manages various personnel functions such as hiring, performanceappraisals, coaching, disciplinary actions and terminations. Provides guidanceand support to staff and orients and mentors new research team members.

10.Performs other related duties.

Qualifications

• Bachelor's degree in Nursing, Biology, and Public Health or related scientific/health field, Masters preferred.
• 6+ years of experience managing clinical trials, including 2 years in a management/leadership role

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Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 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 more than 9,000 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, top 5 in Cardiology/Heart Surgery, and top 20 in 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. 11 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.

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