Clinical Research Coordinator, Full Time Regular, Dayshift

Located in one of the most beautiful regions in the United States, St. Helena Hospital was founded in 1878 and has a rich history of innovative medical care. We are comprised of a 151-bed hospital, emergency department and medical offices with centers of excellence in specialty care, including Adventist Heart and Vascular Institute, Coon Joint Replacement Institute, Martin-O'Neil Cancer Center and Behavioral Health units. In the heart of Napa Valley, St. Helena is a charming place, and the quality of life is unsurpassed with outdoor adventure, rejuvenation at luxurious spas, popular restaurants, as well as perfect weekend getaways to San Francisco or the coast.

Job Summary:

Coordinates and participate in clinical research studies conducted by principal investigator(s). Coordinates and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Coordinates and performs study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes. Applies substantial knowledge and experience to perform a wide range of advanced activities and/or determines how to use resources to meet schedules and goals; serves as working supervisor for team or work group. Coordinates small program(s) with limited budget/impact.

Job Requirements:

Education and Work Experience:

• Bachelor's Degree or equivalent (some certifications will require Bachelor's): Required
• Master's Degree: Preferred

Licenses/Certifications:

• Clinical Research Coordinator Certification: Preferred

Essential Functions:

• Coordinates and implements procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Codes, evaluates and interprets collected data and prepares appropriate documentation. Obtains blood samples, cultures, tissues and other specimens for laboratory analysis.
• Ensures compliance with protocol guidelines and requirements of regulatory agencies. Identifies problems and/or inconsistencies and monitors patients' progress to include documentation and reporting of adverse events. Recommends corrective action as appropriate.
• Evaluates and interprets collected clinical data in conjunction with principal investigator(s) as appropriate. Prepares oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions.
• Assures compliance of general and study specific regulatory related processes and applicable regulations for the reporting of events to regulatory agencies.
• Develops appropriate regulatory reports and associated documentation in accordance with standard of practices and study specific processes, and maintains primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate committees.
• Performs other job-related duties as assigned.

Organizational Requirements:

Adventist Health is committed to the safety and wellbeing of our associates and patients. Therefore, we require that all associates receive all required vaccinations as a condition of employment and annually thereafter, where applicable. Medical and religious exemptions may apply.

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About Us

Adventist Health is a faith-based, nonprofit, integrated health system serving more than 100 communities on the West Coast and Hawaii with over 440 sites of care, including 27 acute care facilities. Founded on Adventist heritage and values, Adventist Health provides care in hospitals, clinics, home care, and hospice agencies in both rural and urban communities. Our compassionate and talented team of more than 38,000 includes employees, physicians, Medical Staff, and volunteers driven in pursuit of one mission: living God's love by inspiring health, wholeness and hope.