Clinical Research Coordinator - Per Diem, Day Shift
About the role
Coordinates and participates in clinical research studies conducted by principal investigator(s). Coordinates and participates 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 with 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.
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.
Education and Work Experience
- Bachelor’s Degree or equivalent (some certifications will require Bachelor’s): Required
- Master's Degree: Preferred
- Clinical Research Coordinator Certification: Preferred
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. Adventist Health participates in E-Verify.