General Summary of Position We are actively recruiting for a Manager Clinical Trials to join our team at MedStar Health Research Institute in Washington, DC. Serves as one of the managers and facilitators of operations of the clinical trials. The manager provides back-up for clinical research coordinators activities. Primary Duties and Responsibilities
Coordinates and establishes clinical trial distribution, task assignments and allocation of staff and equipment. Functions as the primary source of contact for all issues related to research in the respective area. Oversees, coordinates, and monitors the progress of all trials in respective area.Ensures Clinical research studies are conducted according to regulatory requirements, Good Clinical Practices( GCP), specific research protocols, Federal and/or State regulatory agencies and Medstar Health policies and procedures.Communicates with sponsors, Investigators, Clinical monitors and colleagues to ensure effective trial implementation and progress.Completes clinical course of study subjects as required per protocol, including, but not limited to, laboratory tests, vital sign measurement EKGs, health status assessment and adverse event monitoring. Coordinates protocol implementation and document processing for clinical trials, including but not limited to, patient screening & recruitment, informed consent process, study enrollment and patient follow up.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 staff.Monitors protocol deviations for all clinical trials and provide reports of these deviations to the appropriate leaders (PI, SCA, IRB or compliance).Prepares and analyzes regular reports of research activity, including MHRI monthly billing forms, IRB continuations & closures, and patient enrollment logs. Provides regular reports to the SCA/PI on progress on trials.
Minimum Qualifications Education
- Bachelor's degree in health-related field required, and equivalent work experience and education where the objectives of the position are equaled required
Experience
- 2 years management/supervisory experience in a clinical research environment preferred
- 3-4 years experience in clinical trials research required
Knowledge, Skills, and Abilities
- Familiarity with all aspects of conduct of grant-funded and/or industry sponsored clinical trials preferred.
- Familiarity with computerized tracking tools/database experience a plus.
This position has a hiring range of $80,995 - $152,027
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