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.
To apply for this job please visit jobicy.com.
