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Reference Number:
10-10967
Job Description:
Oversee the conduct of assigned clinical studies including acting as liaison to clinical investigators, ensuring the quality and integrity of data. Regional position. Prepare and conduct study initiation, closeout and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols and project plans in accordance with FDA regulations. Maintain site files, trial master files and study documentation. Develop status reports, SOP revisions and document quality control. Review and process regulatory documentation, ensure the execution of clinical trials in a timely, efficient manner, working within established timelines and budgets. Track clinical trial supplies, patient recruitment activities, and Serious Adverse Events, review Case Report Forms for accuracy and completeness and conduct query resolution. Identify investigator sites for participation in trials and organize investigator meetings. Seasoned Clinical Research Associate with 5+ yrs of monitoring experience. Experience managing studies at multiple studies at various locations - regionally or nationally. May be home-based.
Experience Level:
5+ Years
Requirements:
BA/BS in nursing and/or life or health sciences. A minimum of 5 years experience in clinical research; 3+ years as a clinical site monitor Experience with device trials strongly preferred. Sound working knowledge of the Code of Federal Regulations, Good Clinical Practice and ICH guidelines as applied to drug trials. Ability to establish and maintain effective working relationships with study site personnel other team members. Ability to communicate in a professional but results-driven manner with both site coordinators as well as surgeons. Sound knowledge of medical terminology, particularly spine and related pathologies. Able to review and interpret patient medical records and draw concise conclusions.
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