Clinical Research Associate II (FSP)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Role and Responsibilities Summary:

• 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 serve 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.

Originally posted on Himalayas