Job DescriptionThe Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This individual instructs staff regarding appropriate protocols; provides support for ongoing research projects and provides administrative oversight regarding staff roles and instructions for each study.
Responsibilities1.Manages and coordinates assigned clinical trial research studiesconducted by a principal investigator to ensure conformance with specifiedresearch objectives and protocols.
2.Coordinates and establishes clinical trials schedules, task assignmentsand 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 regulatoryrequirements, good clinical practices and specified research protocols,including Mount Sinai School of Medicine, outside sponsors and federal and/orstate regulatory agencies.
5.Serves as the primary liaison for clinical trials conducted forpharmaceutical companies. Provides status reports, adverse side effects andtrends, evaluates patient enrollment and provides appropriate recommendationsand/or conclusions.
6.May monitor and reconcile budget and other financial items for clinicaltrials; tracks reimbursements from the sponsoring agency (ies).
7.Develops policies and procedures for clinical trials; conducts meetingswith staff to ensure compliance with established practices and to keepemployees abreast of current changes and standards.
8.Organizes grant submissions and implements standard operating proceduresfor clinical monitoring. Manages and monitors sites involved in clinicaltrials including the recruitment and management of subjects.
9.Manages various personnel functions such as hiring, performanceappraisals, coaching, disciplinary actions and terminations. Provides guidanceand support to staff and orients and mentors new research team members.
10.Performs other related duties.
Qualifications- Bachelor's degree in Nursing, Biology, and Public Health or related scientific/health field, Masters preferred.
- 6+ years of experience managing clinical trials, including 2 years in a management/leadership role
