CLINICAL PROGRAM MANAGER - Part Time - Tich Cancer Institute - Mount Sinai Hospital
A part-time Clinical Program Manager position is currently available within Tisch Cancer Institute, Division of Hematology/Medical Oncology. The Clinical Program Manager is responsible for coordinating and managing clinical research protocols for our Immunology team, 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.
Roles and Responsibilities:
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.
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 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 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.
May monitor and reconcile budget and other financial items for clinical trials; tracks reimbursements from the sponsoring agency(ies).
Develops 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.
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.
Assist Investigator(s) with developing IITs multi-institutional consortium set up to coordinate, facilitate, and perform basic and clinical research.
Performs other related duties, as appropriate.
Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred.
New York State License with current registration as a registered professional nurse.
4 years of experience managing clinical trials
At least 1 year experience 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