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An established industry player is seeking a dedicated Clinical Trial Manager to oversee day-to-day activities of clinical trials. This role involves ensuring adherence to Good Clinical Practice (GCP), managing data, and training staff to maintain high standards in clinical research. The ideal candidate will contribute to developing workflows and training documents while participating in vital work groups. Join a forward-thinking organization committed to advancing healthcare and education, where your expertise will help shape the future of clinical research and improve community health.
Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Responsibilities include running portions of clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensures all study procedures are conducted according to the protocol and applicable regulations. May assist with the orientation and training of new staff. Contributes to the development of workflows, training documents, and SOP/guidance document revisions. Participates in work groups.
Oversees the day-to-day activities of a clinical trial in accordance with GCP. Trains and supervises research staff on proper procedures for conducting a clinical trial per GCP. Prepares and submits all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol to ensure compliance in a timely manner. Maintains accurate subject logs, tracks expenses, and submits documentation to the Grant Administrator monthly for payments related to study visits. Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP. Organizes and maintains documentation of all patient data. Designs electronic capture databases, if appropriate, and manages all collected data. May provide clerical and technical support to ensure adherence to research protocols and the quality of received information.
Rotating (United States of America)
Regular
901 Walnut Street, Philadelphia, Pennsylvania, United States of America
Jefferson, located in the greater Philadelphia region, Lehigh Valley, Northeastern Pennsylvania, and southern New Jersey, is reimagining healthcare and higher education to create unparalleled value. With over 65,000 staff, Jefferson is dedicated to providing high-quality, compassionate clinical care, making communities healthier, preparing future professionals, and advancing research. Thomas Jefferson University, established in 1824, offers diverse undergraduate and graduate programs. Jefferson Health, ranked among the top 15 non-profit healthcare systems nationally, operates numerous hospitals and outpatient facilities in the region. Jefferson Health Plans provides health coverage options in Pennsylvania and New Jersey for over 35 years.
Jefferson is committed to equal educational and employment opportunities for all persons regardless of age, race, color, religion, creed, sexual orientation, gender, marital status, pregnancy, national origin, ancestry, citizenship, military or veteran status, disability, or other protected groups.