The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Provides regular site status information to team members, trial management, and updates trial management tools
Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
Performs essential document site file reconciliation
Performs source document verification and query resolution
Assesses IP accountability, dispensation, and compliance at the investigative sites
Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
Communicates with investigative sites
Updates applicable tracking systems
Ensures all required training is completed and documented
Serves as observation visit leader
Facilitates audit s and audit resolution
Read, write and speak fluent English; fluent in host country language required.
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
Clinical research experience
Knowledge of ICH and local regulatory authority regulations regarding drug
An advanced degree (e.g., M.S., M.B.A., PharmD, etc)
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.