Clinical Research Associate

PRA Health Sciences 

Location Mumbai,

ACCOUNTABILITIES

Working for either our Product Registration or Strategic Solutions Department, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

As Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend people’s lives in oncology, general medicine and eye care. Working in this way, you will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.

The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle.

Key responsibilities

• Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.

• Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.

• Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines, status (problems encountered, and time remaining to complete) to the appropriate stakeholders.

• 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 onsite or remotely

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

• Completes monitoring activity documents as required by PRA 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 PRA SOPs, until identified issues are resolved or closed

• Performs essential document site file reconciliation

• Performs source document verification and query resolution

• Assesses IP accountability, dispensation, and compliance at the investigative sites

• Verifies Serious Adverse Event (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 observation visit leader

• Facilitates audit s and audit resolution

• Mentors junior level CRAs and serves as a resource for new employees

• Serves as observation and performance visit leader

• May be assigned additional Clinical Operations tasks

• May serve as a resource for and interact with other functional areas to resolve site

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