康德弘翼医学临床研究有限公司 ea jobs (salary & requirements)

工作职责:
1. The Clinical Research Associate (CRA) will monitthe progress of clinical studies at investigative sites remotely, ensure clinical trials are conducted, recorded, and
reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, all applicable, Regulatory requirements.
2. Implements monitors local clinical trials to ensure sponsinvestigatobligations are being met are compliant with applicable local regulatory requirements 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, close clinical trials at investigative sites
4. Reviews verifies accuracy of clinical trial data collected, either onsite remotely
5. Provides regular site status information to team members, trial management, updates trial management tools
6. Completes monitoring activity documents as required by Company SponsSOPs other contractual obligations
7. Works closely with other clinical team members to facilitate timely resolution of trial and/clinical issues
8. Escalates site trial related issues per Company SOPs, until identified issues are resolved closed
9. Performs essential document site file reconciliation
10. Performs source document verification query resolution
11. Assesses IP accountability, dispensation, compliance at the investigative sites
12. Verifies Serious Adverse Event (SAE) reporting according to trial specifications relevant local ICH GCP guidelines
13. Communicates with investigative sites
14. Updates applicable tracking systems
15. Ensures all required training is completed documented
16. Be assigned logistical support tasks by CTM fInvestigatMeetings
任职资格:
1. 1 to 3 years of local trial experience; exposure to MNC global Local Phase I -IV trials Clinical research experience
2. Knowledge of ICH local regulatory authority regulations regarding drug
3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)
职位福利：五险一金、绩效奖金、年底双薪、弹性工作、节日福利、周末双休