- 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
- 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 tool.
- Completes monitoring activity documents as required by Company or Sponsor 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 Company 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 relevant local and ICH GCP guidelines
- Communicates with investigative sites
- Updates applicable tracking systems
- Ensures all required training is completed and documented
- Be assigned logistical support tasks by CTM for Investigator Meetings
临床监查员cra(j20385) - Zhengzhou, 中国 - WuXi AppTec
描述
职位描述:
任职资格:
1. 1+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 (., ., ., .,