Senior, Clinical Research Associate Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: Clinical/Regulatory
Help write clinical protocols for beta site and formal clinical studies; sets up and monitors clinical trials for new investigational products, including instruments and test devices. Identifies external sources for patient samples needed for product development and/or drafts protocols for external specimen collection. Provide guidance to product development teams about requirements for clinical field studies. Monitors conduct of clinical studies. Prepares, handles, distributes, files, and archives clinical documentation and reports; reviews clinical study files periodically for accuracy and completeness. Prepares and distributes clinical trial supplies and maintains related tracking information. Tracks and manages Case Report Forms (CRFs) and Data Report Forms (DRFs). Participate in data entry, data auditing, clinical site queries and overall clinical data flow from the various clinical sites in a timely and professional manner. Prepare documentation for obtaining IRB approvals. Actively participate in analysis of data, including the drafting of clinical study reports. Ensure compliance with good clinical practice, U.S. QSR and ISO9000 regulations. Maintain a high level of professional expertise through familiarity with clinical literature and current regulations. Interact with study coordinators and study participants. Travel to clinical trial sites for study initiation, interim monitoring, and closure. Primary Responsibilities: Work closely with project teams to develop clinical trials. Initiate, monitor and audit field clinical trial sites. Manage and secure IRB study approvals. Work with principal investigators on study publications. Prepare clinical trial data for regulatory submissions. Procure, manage and process clinical specimens. Identify and enroll principal investigators for field trials.
BS/BA in a biological science or Medical Technologist degree (or equivalent combination education and/or work experience). At least 5 to 7 years clinical experience in the IVD or medical device industry. Certification in clinical trials design and management highly desirable. Strong knowledge of medical terminology and clinical practices. Strong interpersonal & communication skills (written & verbal) Typically travels to field sites to initiate, supervise and monitor clinical studies.
||San Diego, CA |
THIS JOB HAS EXPIRED