
Clinical Trials Operations Specialist
3 days ago
The Clinical Trials Monitoring Assistant/Manager is responsible for ensuring compliance with all related regulatory policies and guidelines. Under the direction of Clinical Trials Office Leadership, they will assist in the design, development, implementation, and conduct of an effective monitoring program.
Responsibilities include ensuring the Sponsor-Investigator and study team adhere to current regulations, adhering to protocols' Data Safety Monitoring Plans, and verifying that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation.
Required Skills and Qualifications:">- ">
- 10 years of progressively responsible clinical trials experience with 3 years of monitoring experience.">
Experience in an academic institution or pharma MNC/CRO is preferred, especially working in collaborative efforts with upper administrators, faculty, and research staff as well as research support personnel.
Benefits:">As a Clinical Trials Monitoring Assistant/Manager, you will have the opportunity to work on multiple projects at a time, promoting a culture of monitoring compliance and regulatory awareness.
Others:">A willingness and ability to travel occasionally are required for this position.
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