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.