Key Accountabilities:

Study Team Supporting

• 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 on site or remotely. 

• Provides regular site status information to team members, trial management, and updates trial management tools. 

• Completes monitoring activity documents as required by 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 SOPs until identified issues are resolved or closed. 

• Performs essential document site file reconciliation. 

• Performs source document verification and query resolution.

• Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites. 

• Verifies 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 main observer/assessor of site activities. 

• Facilitates audits and audit resolution. 

• To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g., protocol amendment submissions, Investigator site budget negotiation. 

• Mentors’ junior-level CRAs and serves as a resource for new employees. 

• Serves as main observer of site activities and may have some responsibilities for performance of site. 

• May be assigned additional clinical operations tasks: 

• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines. 

• May be assigned clinical tasks where advanced negotiating skills are required