Clinical Trials Manager - Center for Interventional Cardiovascular Research & Clinical Trials
About The Position
The Clinical Trials Manager coordinates and manages clinical research protocols, which may include projects sponsored by pharmaceutical companies. The role instructs staff on appropriate protocols, supports ongoing research projects, and assists with day-to-day staff oversight and study instructions. The manager oversees assigned clinical trial studies conducted by a principal investigator, ensuring they conform to research objectives, protocols, regulatory requirements, and good clinical practices. The position coordinates study schedules, tasks, staff, equipment, and enrolled subjects; oversees case report form data, drug accountability, and regulatory documentation; and serves as a liaison for pharmaceutical-company trials. The manager reports on study status, adverse effects and trends, and enrollment, and provides recommendations or conclusions. The role also monitors trial budgets and sponsor payments, helps develop operating policies and procedures, conducts staff meetings, organizes grant submissions, and implements standard operating procedures for clinical monitoring. It manages and monitors trial sites, including subject recruitment and management, and may assist with personnel functions. The manager provides staff guidance and support and orients and mentors new research team members.
Requirements
- Bachelor's degree in Biology, Public Health, or a related scientific or health field.
- 4–5 years of research experience with exposure to clinical trials.
- 1 year in a management or leadership role.
Nice To Haves
- Master's degree preferred.
- Experience in cardiovascular research or interventional clinical trials strongly preferred.
Responsibilities
- Manage and coordinate clinical trial research studies conducted by a principal investigator to ensure conformance with research objectives and protocols.
- Coordinate clinical trial schedules, task assignments, and allocation of staff and equipment.
- Coordinate and manage subjects enrolled in clinical trials, completion of Case Report Forms (CRFs), drug accountability, and completion and tracking of regulatory documents.
- Ensure studies follow regulatory requirements, good clinical practices, and specified research protocols, including those of Mount Sinai School of Medicine, outside sponsors, and federal and state regulatory agencies.
- Serve as liaison for clinical trials conducted for pharmaceutical companies.
- Provide status reports on adverse side effects and trends, evaluate patient enrollment, and provide appropriate recommendations or conclusions.
- Monitor and reconcile clinical trial budgets and ensure timely receipt of payments from sponsoring agencies.
- Assist with developing clinical trial operating policies and procedures and conduct staff meetings to support compliance and keep employees informed of changes and standards.
- Organize grant submissions and implement standard operating procedures for clinical monitoring.
- Manage and monitor clinical trial sites, including recruitment and management of subjects.
- May assist with hiring, performance appraisals, coaching, disciplinary actions, and terminations.
- Provide guidance and support to staff and orient and mentor new research team members.
- Perform other related duties.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
