Tuesday, September 24, 2013

Clinical Research Associate - Home Based Regional


The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, and all applicable regulatory requirements.


1. 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

2. 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

3. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely

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

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

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

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

8. Performs essential document site file reconciliation

9. Performs source document verification and query resolution

10. Assesses IP accountability, dispensation, and compliance at the investigative sites

11. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH‐GCP guidelines

12. Communicates with investigative sites

13. Updates applicable tracking systems

14. Ensures all required training is completed and documented

15. Serves as observation visit leader

16. Facilitates audit s and audit resolution

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

18. Serves as observation and performance visit leader

19. May be assigned additional Clinical Operations tasks

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

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

PRA is an Equal Employment Opportunity / Affirmative Action Employer

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