Clinical Research Coordinator, Per Diem, Day Shift, St Helena
About The Position
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.
Requirements
- Bachelor's Degree or equivalent (some certifications will require Bachelor's): Required
Nice To Haves
- Master's Degree
- Clinical Research Coordinator Certification
Responsibilities
- 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.
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What This Job Offers
Job Type
Part-time
Industry
Religious, Grantmaking, Civic, Professional, and Similar Organizations
Number of Employees
5,001-10,000 employees
