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Clinical Trials Manager

Full/Part Time: Full Time
Department: 821 - Cardiology
Requisition Number: 14-1671652

Job Description:

The Manager, Clinical Trials is accountable 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, 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 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. 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. 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.

Job Qualifications:

Bachelor's Degree in Biology, Public Health or related scientific/health field

4 years of experience managing clinical trials

1 year in a management/leadership role

Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds. Mount Sinai Medical Center--An EEO/AA-D/V Employer.

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