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    clinical trials manager - The Bronx, United States - Montefiore Medical Center

    Montefiore Medical Center
    Montefiore Medical Center The Bronx, United States

    4 weeks ago

    Default job background
    Regular Full time
    Description

    Working under general supervision of the Assistant Director of Clinical Trial Operations, this position assumes responsibility for the overall management of assigned clinical trials/studies. These responsibilities include timely submission of all regulatory reports and communication of the clinical trial status to management. Maintains compliance with all regulatory bodies associated with human subject and devices research. Position will oversee at least one full-time Clinical Trial Specialist and one Research Assistant and will be responsible for meeting enrollment targets for studies. The manager is responsible for the development of recruitment methods to increase patient randomization into the trial, delivery of materials for clinical trials, and coordinating the trial to make sure it runs smoothly. A clinical trial manager also spends a great deal of time communicating with other professionals via phone, email, and face-to-face meetings to make sure the whole clinical trial team is consistently aware of any relevant information and issues.

    Required

    Bachelor's Degree

    3 years clinical research experience required (5 years preferred)

    Knowledge of NIH and FDA regulations regarding clinical trials

    Proficiency with computers (i.e., MS Office, database, Internet)

    Good communication and organizational skills;

    Training preferred not required:
    Completion of the Collaborative IRB Training Initiative (CITI), GCP, EPIC, Velos, Modified Rankin, NIH Stroke Scale, and IATA (International Airport Transportation) training courses

    Certified Clinical Research Coordinator by Association for Clinical Research Professionals

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