Strength Through Diversity
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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.
Duties and Responsibilities
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, completion of data for Case Report Forms (CRF), drug accountability and the completion and tracking of regulatory documents for clinical trials.
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 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. Monitors and reconciles the budget for all clinical trials; ensures payments from the sponsoring agency are received in a timely manner.
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. 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.
10. 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
Licensing and Certification Requirements
MS Office Suite (please check one): (basic) (intermediate) (advanced)
General Skills and Competencies
1. Excellent written, oral and interpersonal skills
2. Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance
3. Proven ability to provide scientific and clinical expertise in all phases of clinical trials
4. Excellent analytical and problem solving skills
5. Strong management and leadership skills