Clinical Research Associate
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Job Description
Clinical Research Associate overseeing operational aspects of clinical trials. Supporting site performance and ensuring regulatory compliance with GCP guidelines across various indications.
Responsibilities:
- Oversee the operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to Good Clinical Practice (GCP) guidelines.
- Support multiple clinical trials across various therapeutic indications and monitor site performance, resolving issues, and facilitating communication between sponsor and site personnel.
- Evaluate clinical trial resourcing requirements for qualification (SQVs), training (SIVs), monitoring (IMVs) and support of sites during the conduct of the trials.
- Work with multiple trial sites and multiple studies of varying indications simultaneously.
- Develop and maintain a monitoring plan for assigned clinical trial(s).
- Liaise with external clinic and/or hospital investigators and associated staff conducting the trial as required.
- Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study.
- Oversee site activation process for each study.
- Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
- Track patient enrollment and recommend solutions to trial site staff to increase appropriate enrollment of qualified subjects.
- Provide support for the processing of data queries, deviations, adverse events, etc.
- Write monitoring visit reports.
- Develop and execute a plan to close trial sites on completion of the trial and perform associated close-out activities.
Requirements:
- Bachelor's degree required, preferably in Clinical Research, Life Sciences, or a related field
- Equivalent clinical experience may be considered in lieu of a degree, including experience as a Physician Assistant (PA), Registered Nurse (RN), Emergency Medical Technician (EMT), or other relevant healthcare professional
- Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred
- 3 years of relevant experience, preferred with at least two years of experience in industry or has worked with Sponsor companies as a clinic coordinator
- Prior study supervision experience required
- Valid class C driver's license required
- Clearance of favorable background investigation required
Benefits:
- Flexible to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
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