Clinical Research Coordinator, Full Time Regular, Dayshift
About The Position
The Clinical Research Coordinator coordinates and participates in clinical research studies conducted by principal investigators. The role coordinates complex activities involving collection, compilation, documentation, and analysis of clinical research data, as well as study-specific regulatory processes across studies involving different therapeutic areas and phases. Work must follow applicable regulations, Standard Operating Procedures (SOPs), study protocols, plans, and processes. The coordinator applies substantial knowledge and experience to advanced activities and resource planning, serves as a working supervisor for a team or work group, and coordinates small programs with limited budget or impact. The position is based at St. Helena Hospital, part of Adventist Health. The schedule is full-time, regular, dayshift.
Requirements
- Bachelor’s degree or equivalent is required; some certifications will require a bachelor’s degree.
- Knowledge and experience sufficient to perform a wide range of advanced activities and/or determine how to use resources to meet schedules and goals.
- Ability to coordinate and participate in clinical research studies and related data collection and regulatory processes.
Nice To Haves
- Master’s degree preferred.
- Clinical Research Coordinator certification preferred.
Responsibilities
- Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources.
- Code, evaluate, and interpret collected data and prepare appropriate documentation.
- Obtain blood samples, cultures, tissues, and other specimens for laboratory analysis.
- Ensure compliance with protocol guidelines and regulatory agency requirements.
- Identify problems or inconsistencies and monitor patient progress, including documenting and reporting adverse events; recommend corrective action as appropriate.
- Evaluate and interpret clinical data with principal investigators as appropriate.
- Prepare oral presentations, written reports, and analyses describing progress, trends, and recommendations or conclusions.
- Ensure compliance with general and study-specific regulatory processes and applicable requirements for reporting events to regulatory agencies.
- Develop regulatory reports and related documentation according to standards of practice and study-specific processes.
- Assess, complete, and submit protocol-related documents to appropriate committees, maintaining primary responsibility for a variety of regulatory tasks.
- Perform other job-related duties as assigned.
- Coordinate clinical research studies and complex activities involving collection, compilation, documentation, and analysis of research data.
- Coordinate and participate in study-specific regulatory processes across multiple studies, therapeutic areas, and phases.
- Serve as a working supervisor for a team or work group and coordinate small programs with limited budget or impact.
Benefits
- Required vaccinations as a condition of employment and annually thereafter, where applicable; medical and religious exemptions may apply.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
