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.
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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