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.

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

Flexible to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary

Clinical Research Associate

Key skills