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

The Clinical Trials Manager is responsible for coordinating and managing clinical research protocols, which may include projects from pharmaceutical companies. Instructs staff regarding appropriate protocols; provides support for ongoing research projects and assists in staff oversight in day to day activity and instructions for each study.

• Manages and coordinates assigned clinical trial research studies conducted by a principal investigator to ensure conformance with specified research objectives and protocols. 
• Coordinates and establishes clinical trials schedules, task assignments and allocation of staff and equipment. 
• Coordinates and manages all subjects enrolled in clinical trials, completion of data for Case Report Forms (CRF), drug accountability and the completion and tracking of regulatory documents for clinical trials.
•  Ensures clinical research studies are conducted according to regulatory requirements, good clinical practices and specified research protocols, including Mount Sinai School of Medicine, outside sponsors and federal and/or state regulatory agencies.
• Serves as liaison for clinical trials conducted for pharmaceutical companies. Provides status reports, adverse side effects and trends, evaluates patient enrollment and provides appropriate recommendations and/or conclusions.
• Monitors and reconciles the budget for all clinical trials; ensures payments from the sponsoring agency are received in a timely manner. 
• Assists with the development of operating policies and procedures for clinical trials; conducts meetings with staff to ensure compliance with established practices and to keep employees abreast of current changes and standards. 
• Organizes grant submissions and implements standard operating procedures for clinical monitoring. Manages and monitors sites involved in clinical trials including the recruitment and management of subjects.
• May assist in 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. 
• Performs other related duties.

• Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred
• 4-5 years of research experience with exposure to clinical trials and 1 year in a management/leadership role
• Experience in cardiovascular research or interventional clinical trials strongly preferred