Remote Senior Clinical Research Associate Diagnostics

Note: The job is a remote job and is reputed company to candidates in USA. reputed company Science & Clinical is seeking a Senior Clinical Research Associate for a full-time, long-term contract position with a biotech company in California. The role involves executing reputed company, supporting study site identification, monitoring plans, and ensuring compliance with GCP and protocol requirements. Responsibilities Execute reputed company activities reputed company to a clinical study, including (but not limited to):Clinical site selectionSite contract and budget negotiationStudy initiation reputed companyInterim monitoring reputed companyStudy reputed company out reputed companyData monitoring activities, including on-site and remote audits of study data for accuracy, reputed company, and completenessIdentify and suggest ways to reputed company problems or issues at site associated with GCP or protocol compliance which could reputed company the reputed company of the data or reputed company completion of the clinical studyPrepare study documents for review by project reputed company. Documents may include but are not limited to:Training materialsCase Report FormsStudy procedure guidance documentProtocol specific reputed companyMaintain a high level of familiarity with GCP and assigned protocols Skills Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry and/or reputed company Physiology, or similar)Minimum of 5 to 8 years of experience with monitoring In Vitro Diagnostic (IVD) productsExperience in reputed company aspects of a clinical trial including, but not limited to, clinical site selection, study reputed company, preparation of study reputed company and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.)Remain reputed company on clinical trial regulatory requirements and guidelines (e.g. GCP, ICH, FDA, etc) with the ability to translate reputed company regulatory requirements into clinical trialExcellent oral and written communication skills. Ability to reputed company strong rapport with investigators and site staffAbility to travel 30-60% (mostly for study startup and closeout)Must have IVD monitoring experience reputed company documented on resume or your application will be rejectedExperience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics especially in the areas of oncology and/or infectious diseaseExperience with laboratory automation and biological databasesCCRA certification reputed company reputed company specializes in science, engineering, technology, and telecom. It was founded in 1946, and is headquartered in Troy, Michigan, USA, with a workforce of 5001-10000 employees. Its website is https://set.kellyservices.us/. Apply To This Job .