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CLINICAL RESEARCH SPECIALIST JOB

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CLINICAL RESEARCH SPECIALIST

JOB DESCRIPTION:

    All Clinical Trials personnel assume a critical role in the success of the clinical trials from protocol development through the audit of data collected during the study. Specific areas of responsibilities for the Clinical Research Specialist position may include processing tracking of IRB sponsor required documents, mentoring investigators in the IRB process keeping track of certifications for all personnel.
      Prepares maintains regulatory documents other necessary documents relating to clinical trials their sponsors.
      Prepares processes IRB documentation through the IRB, including new submissions, continuing reviews, amendments adverse event reporting.
      Organize maintain documentation required by sponsor or CRO (RO forms, 1572s, deviation exception memos, physicians coordinators CVs medical licenses, record of IRB certification compliance source documentation, case report forms, study regulatory binders patient binders).
      Interacts with co-workers, visitors other staff consistent with the core values of the University.
        EDUCATIONAL/TRAINING REQUIREMENTS: Associates degree required. Bachelors degree preferred.
      CERTIFICATES, LICENSES, AND REGISTRATION:
      .
        Must successfully complete Human Subjects training course at Thomas Jefferson University within 6 months of hire.
        Being Able to design manage Microsoft Access database.
        Thomas Jefferson University Thomas Jefferson University Hospitals are partners in providing excellent clinical compassionate care for our patients in the Philadelphia region, educating the health professionals of tomorrow in a variety of disciplines discovering new knowledge that will define the future of clinical care.
        Thomas Jefferson University is composed of Sidney Kimmel Medical College at Thomas Jefferson University, Jefferson College of Biomedical Sciences the Jefferson Schools of Health Professions, Nursing, Pharmacy Population Health. The University enrolls more than 3,200 future physicians, scientists healthcare professionals. Founded in 1824, Jefferson Medical College is one of the largest private medical schools in the nation, with among the largest living alumni group.
        As an academic medical center within a regional healthcare system, Thomas Jefferson University Hospitals are dedicated to excellence in patient care, patient safety the quality of the healthcare experience. U.S. News and World Report has ranked Thomas Jefferson University Hospitals among the best hospitals in the nation has recognized a number of its specialties including orthopedics, rehabilitation medicine, cancer, digestive diseases, ear, nose throat respiratory disorders. Begun in 1825, the Hospital now has 969 licensed acute care beds, with major programs in a wide range of clinical specialties. Services are provided at four locations-the main hospital facility the Jefferson Hospital for Neuroscience, both in Center City Philadelphia, Methodist Hospital in South Philadelphia Jefferson at Voorhees in South Jersey.
        As an employer, Jefferson maintains a commitment to provide equal access to employment. Jefferson values diversity encourages applications from women, members of minority groups, LGBTQ individuals, disabled individuals veterans.

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