At a glanceSummarised by Seekless from the posting.
Must have22
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.
Undertakes 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.
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.
Responsibilities
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.