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:
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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.

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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.

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Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.

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Provides regular site status information to team members, trial management, and updates trial management tools,

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Completes monitoring activity documents as required by SOPs or other contractual obligations.

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Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.

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Escalates site and trial related issues per SOPs until identified issues are resolved or closed.

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Performs essential document site file reconciliation.

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Performs source document verification and query resolution.

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Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.

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Verifies SAE reporting according to trial specifications and ICH GCP guidelines.

- Communicates with investigative sites

- Updates applicable tracking systems.

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Ensures all required training is completed and documented

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Serves as main observer/assessor of site activities.

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Facilitates audits and audit resolution.

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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.

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Mentors’ junior-level CRAs and serve as a resource for new employees.

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

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May be assigned additional clinical operations tasks.

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May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.

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May be assigned clinical tasks where advanced negotiating skills are required.

Originally posted on Himalayas