Job Description
Responsible for supporting the SRPs and investigator for Targeted Sites:
**Clinical Trial Site Activation & Conduct**
- Assist with study site activation activities to ensure timely site activation
- Register investigator sites in Client registries, as required
- Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
- Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status
- Support local IRB workflow from submission through approval and support reporting of updates to safety information
- Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, F...
**Clinical Trial Site Activation & Conduct**
- Assist with study site activation activities to ensure timely site activation
- Register investigator sites in Client registries, as required
- Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
- Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status
- Support local IRB workflow from submission through approval and support reporting of updates to safety information
- Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, F...
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