Regional Clinical Research Associate (CRA) III in NYC
Categories: Pharmaceutical
Description 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.
Requirements:
Seasoned Clinical Research Associate with 5+ yrs of monitoring experience. Experience managing studies at multiple studies at various locations - regionally or nationally.
This position will be home based. It will require some travel to the client site in the beginning for training.
This position is a CRA for a specific study in the NY area. Number of hours worked will vary week to week. It is a standard regional CRA position for a single study.
