Clinical Research Associate

Job highlights

• Ensure that clinical research studies are conducted in accordance with the protocol,standard operating procedures,good clinical practice (GCP) guidelines,and other applicable regulatory requirements.

JOB DETAILS

1. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice (GCP) guidelines, and other applicable regulatory requirements.

2. Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP guidelines.

3. Review informed consent document / procedures.

4. Negotiate study budgets with potential investigators and assists with the execution of site contracts Provide monitoring visits and site management for a variety of protocols, sites

5. Administer protocol and other study-related training to assigned site personnel and establish regular lines of communication with the sites to manage ongoing project expectations and issues.

6. Evaluate the quality and integrity of the practices of the study site related to the proper conduct of the protocol and adherence to applicable regulations.

7. Escalate quality issues to the CPM / line manager, as deemed necessary.

8. Ensure accurate data reporting via review of site source documents and medical records.

9. Interpret data to identify protocol deviations and risks to subject safety/data integrity.

10. Perform investigational product accountability as per the protocol and Study Monitoring Plan.
    FUNCTIONAL AREA
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