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Sr. Clinical Research Associate (In House)

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Company :
MicroVention Inc

Location :
Aliso Viejo, California

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

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Description :
Title Sr. Clinical Research Associate (In-House) Job Description The Sr. CRA supports project managers and/or Director, Post-Market Clinical Programs in post-market clinical research efforts. * Supports startup and execution of post-market clinical studies in line with institutional, GCP, regulatory, and compliance requirements * Assists project managers in protocol development as well as in the IRB/ethics approval process and audit preparation * Reviews and prepares technical documentation including informed consents, case report forms, study tools, and study training documents * Supports study project managers in budget and contract negotiations with clinical sites * Performs study site qualification visits, site initiation visits, and training of site staff, monitors, and vendors * Leads communication with study site/subsite personnel, monitors, vendors, and CROs/coordinating centers * Partners with study project managers to track study data, enrollment trends, and other metricsPerforms other duties and responsibilities as assigned Auto req ID 9456BR Location Aliso Viejo, California, USA Department Name 650-Clinical Admin-Post Market Qualifications * Bachelors Degree in a related field or equivalent experience (life science or engineering preferred) * Minimum of 5 years of clinical research experience preferably in the medical device industry * Experience supporting post-market clinical studies desired * Global and/or IDE/PMA study experience * Protocol development * ICF/CRF experience * Travel required (up to 25%) * In-house position based at Aliso Viejo, CA corporate headquarters * Strong knowledge of clinical research concepts, terminology, and regulations/guidelines such as FDA Title 21 and Good Clinical Practice (GCP) * Ability to understand the clinical therapies, procedures, and devices that form the basis of the organizations research and to review and understand related reports and literature * Ability to identify data trends and prepare related reports * Outstanding detail-orientation and organizational/time management skills * Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and other internal/external business partners * Proficiency in MS Office (Word, Excel, Access, PowerPoint) and Adobe Acrobat * Experience using Electronic Data Capture systems desired External-Facing Title Sr. Clinical Research Associate Posting Country US – United States