Responsible for coordinating and managing all aspects of clinical research protocols including projects from pharmaceutical companies. Instructs staff regarding appropriate protocols; provides support for ongoing research projects and provides administrative oversight regarding staff roles and instructions for each study.
1. Manages and coordinates assigned clinical trial research studies conducted by a principal investigator to ensure conformance with specified research objectives and protocols.
2. Coordinates and establishes clinical trials schedules, task assignments and 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 regulatory requirements, good clinical practices and specified research protocols, including Mount Sinai School of Medicine, outside sponsors and federal and/or state regulatory agencies.
5. Serves as the primary 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.
6. May monitor and and reconcile budget and other financial items for clinical trials; tracks reimbursements from the sponsoring agency(ies).
7. 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.
8. 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.
9. Manages 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.
10. Performs other related duties.