13 days old

Clinical Research Associate II

Sunnyvale, CA 94086

The Clinical Research Associate at Cepheid is primarily responsible for carrying out the responsibilities involved in the execution of IVD clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various stages or phases in the life cycle of the product including alpha (early stage feasibility), beta and most importantly the clinical studies that validate the product.

€¢ Perform internal performance testing such as proficiency and system testing
€¢ Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products
€¢ Identify potential investigators, prepare site budgets and contract agreements
€¢ Collect, review and process regulatory documents and correspondence from participating trial sites
€¢ Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required.
€¢ Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution
€¢ Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
€¢ Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem
€¢ Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance
€¢ Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives

€¢ Complete all assigned and required training satisfactorily and on time
€¢ For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.


Education and Experience (in years):
€¢ Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.

Knowledge and skills:
€¢ Minimum of 2 years of experience with In Vitro Diagnostic (IVD) products
€¢ Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment
€¢ Excellent communication and team skills
€¢ Effective interpersonal skills
€¢ Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
€¢ Experience in the handling and shipping of Bio hazardous specimens.
€¢ Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
€¢ Knowledge of GCP & ICH guidelines and FDA regulations
€¢ Working knowledge of the diagnostic field and clinical trial material that is to be studied
€¢ 30-50% travel required

€¢ Good understanding of medical terminology, human physiology and laboratory testing
€¢ Knowledge of regulatory and clinical practices (GCP, ICH)
€¢ Experience with laboratory automation and biological databases
€¢ Previous hands-on experience in clinical research at either a diagnostic company/hospital or laboratory
€¢ Knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, and the current gold standard for the diagnosis of disease
€¢ Must be detailed oriented, with strong time management and organizational skills

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.


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 €œEEO is the Law€ poster is available here.","industry":"Biotechnology


Posted: 2020-05-21 Expires: 2020-06-20

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Clinical Research Associate II

Sunnyvale, CA 94086

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