job title: clinical research associate 2(icon)

Responsibilities:

• 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 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

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

• Serves as observation and performance visit leader

• 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

You are:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field

• Minimum of 2 years of independent on-site monitoring experience in clinical trials

• Previous exposure to global oncology studies in Phase I, II, or III

• Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements

• Excellent communication, organizational, and problem-solving skills

• Ability to manage multiple priorities and work independently

• Willingness to travel as required for site visits