工作職責(zé):
1. 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.
2. Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines
3. 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
4. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
5. Provides regular site status information to team members, trial management, and updates trial management tools
6. Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations
7. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
8. Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed
9. Performs essential document site file reconciliation
10. Performs source document verification and query resolution
11. Assesses IP accountability, dispensation, and compliance at the investigative sites
12. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines
13. Communicates with investigative sites
14. Updates applicable tracking systems
15. Ensures all required training is completed and documented
16. Be assigned logistical support tasks by CTM for Investigator Meetings
任職資格:
1. 1 to 3 years of local trial experience; exposure to MNC and global or Local Phase I -IV trials Clinical research experience
2. Knowledge of ICH and local regulatory authority regulations regarding drug
3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)