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regulatory affairs in Raleigh

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  1. Senior Clinical Research Associate

    We are looking for CRAs with at least 6 years monitoring experience and 3-4 years in Oncology .  .   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ensures proper storage, ...

  2. Senior Project Manager

     Note: Candidates must possess Ph. 1 and 2 Full Service Oncology PM Experience ~~SUMMARY: The Clinical Operations Senior Project Manager (SPM) is responsible for overall management of all phases of clinical trials, from start-up through completion of activities, utilizing MedSource or sponsor Standard Operating Procedures (as applicable), FDA regulations, and ICH-GCP guidelines.  In-depth knowledge and experience of the drug development process is required, including study initiation, clinical ...

  3. Regulatory Affairs Specialist

    ~~SUMMARY: • The Regulatory Affairs Specialist supports the Company’s regulatory function and project teams through the provision of a variety of administrative and technical tasks involving the management of clinical research trials documentation. In addition, the Regulatory Affairs Specialist performs a variety of research, database, and administrative duties of a routine and technical nature in support of corporate initiatives and clinical trials to assist MedSource and/or clients in organizing, ...