Senior Coordinator, Clinical Research

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          "text": "<p>Responsible for coordinating and facilitating the daily activities that play a critical role of the clinical studies according to the protocol, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations.&#xa0;</p><ul><li>Sets up and conducts study in compliance with protocol, SOPs, applicable regulations and GCPs&#xa0;</li><li>Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents&#xa0;</li><li>Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information&#xa0;</li><li>Assures for assigned studies, clinic is set up at least 30 minutes prior to the study start&#xa0;</li><li>Report to clinic on-time for all other studies&#xa0;</li><li>Assures that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs&#xa0;</li><li>Assists in training and mentoring new clinic staff&#xa0;</li><li>Prepares for and conducts pre-study meetings as well as other meetings and processes as deemed necessary by management&#xa0;</li><li>Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports&#xa0;</li><li>Coordinates scheduling subjects for visits&#xa0;</li><li>Responds to queries from Quality Assurance and Statistics departments&#xa0;</li><li>Orders checks for subject compensation&#xa0;</li><li>Prepares and is accountable for all Test Material for managed studies&#xa0;</li><li>Adheres to study budget&#xa0;</li><li>Leads Training Workshops when applicable&#xa0;</li><li>Initiate electronic questionnaire creation&#xa0;</li><li>Assist in IRB and Regulatory Document submission/review&#xa0;</li><li>Provides excellent customer service to clients and panelists and maintains a positive and respectful interaction with peers and supervisors.&#xa0;</li><li>Complies with and understands safety and Operational Integrity procedures and processes.&#xa0;</li></ul>",
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