Oversee the conduct of assigned clinical studies including acting as liaison to clinical investigators, ensuring the quality and integrity of data. May be an in-house or 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. May participate in clinical protocol writing and case report form design. 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.
Requirements:
At least 3-5 years experience required, preferably with devices. Could be regionally based.
