Senior Clinical Research Associate

  • Anywhere

Company :
Leica Biosystems

Location :
Sunnyvale, California

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
ESSENTIAL JOB RESPONSIBILITIES: * Independently execute all activities related to a clinical study, including (but not limited to): * Clinical site selection * Site contract and budget negotiation * Study initiation visits * Interim monitoring visits * Study close out visits * Data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness * Identify and suggest ways to resolve problems or issues which could affect the integrity of the data or timely completion of the clinical study. * Prepare and/or review study protocols and study documents for new and modified products. * Prepare and/or review clinical reports and applicable sections of regulatory submissions and scientific abstracts, posters, and publications. * May serve as the clinical affairs representative on a project team. * Maintain a high level of familiarity with clinical literature in the field of study and related areas and stay up to date on major advances in disease diagnosis and/or detection and the use of new tests and advances in clinical practice. TRAINING RESPONSIBILITIES: (REQUIRED) * Complete all assigned and required training satisfactorily and on time. MINIMUM REQUIREMENTS: Education and Experience (in years): * Bachelor s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry and/or Human Physiology). * Minimum of 5+ years of experience with monitoring In Vitro Diagnostic (IVD) products or medical devices. Knowledge and skills: * Experience in all aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.). * Knowledge of good clinical trial design and basic understanding of statistics. * Remain current on clinical trial regulatory requirements and guidelines (e.g. GCP, ICH, FDA, etc) with the ability to translate current regulatory requirements into clinical trial. * Excellent oral and written communication skills. Ability to develop strong rapport with investigators and site staff. Physical requirements/abilities: * Must be able to lift 15 lbs. Other: Travel * Travel requirements of 20-40% PREFERRED REQUIREMENTS: * Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics especially in the areas of oncology and/or infectious disease * Good understanding of medical terminology, human physiology and laboratory testing * Experience with laboratory automation and biological databases * Experience with CE and/or US-IVD regulatory submissions * CCRA certification Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.