Clinical Research Associate II-Taiyuan

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Key Role and ResponsibilitiesSummary:

• Implements andmonitorsclinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatoryrequirements and ICH GCP guidelines.

• Assesses the qualification of potential investigative sitesinitiatesclinical 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 tofacilitatetimelyresolution of trialand/or clinical issues.

• Escalates site and trial related issues per SOPs untilidentifiedissues are resolved or closed.

• Performs essential document site file reconciliation.

• Performs source document verification and query resolution.

• Assesses investigational product (IP) accountability dispensation and complianceat 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 asmainobserver/assessor of site activities.

• Facilitatesaudits and auditresolution.

• To undertake otherreasonably relatedduties as may be assigned from time to time asappropriate forexperience and amendmentsubmissions Investigator site budget negotiation.

• Mentors junior-levelCRAs andserve as a resource for new employees.

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

• May be assignedadditionalclinical operations tasks.

• May serve as a resourcefor andinteractwith other functional areas to resolve site issues andfacilitatetrial timelines.

• May be assigned clinical tasks where advanced negotiating skills arerequired.