Clinical Research Coordinator - Per Diem, Day Shift
About The Position
Coordinates and participates in clinical research studies conducted by principal investigator(s). This role involves coordinating and performing a variety of complex activities related to the collection, compilation, documentation, and analysis of clinical research data. The coordinator will also manage study-specific regulatory processes across multiple studies in different therapeutic areas and phases, ensuring compliance with regulations, Standard Operating Procedures (SOPs), and study-specific protocols. This position requires substantial knowledge and experience to perform advanced activities and may involve serving as a working supervisor for a team or workgroup. Additionally, the role may involve coordinating small programs with limited budgets or impact.
Requirements
- Bachelor’s Degree or equivalent (some certifications will require Bachelor’s)
- 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.
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, including 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.
- 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.
Benefits
- All required vaccinations as a condition of employment and annually thereafter, where applicable.
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What This Job Offers
Career Level
Mid Level
