職位描述
Coordinates delivery, collection, and review of trial documents to and from investigator sites and the GCSM organization and ensures clinical site documentation is done in accordance with Alcon Standard Operating Procedures (SOPs), Good Clinical Practice (ICH-GCP), Good Business Practices and applicable regulatory requirements.
1. Coordinates delivery and collection of trial documents to and from investigator sites/GCSMs; including facilitating IRB/IEC submissions.
2. Ensures accuracy and quality documents included in the site initiation packets.
3. Enters and maintains site information and document tracking in current clinical systems.
4. Ensures trial documentation is well organized, filed appropriately, and is available and current for the study team.
5. May specialize in preparation of SIP, budgets/contracts, or in other specialized functions as needed.
6. Follows applicable work processes, SOPs, communication plans, etc.
7. Ensures timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budgets and contracts, or other relevant documentation.
8. May provide documents to other GC&RA functions as needed.
9. Works under direction of the lead/manager.
Work may be reviewed for soundess of judgment and overall adequacy and accuracy.
Education:
? University degree in life sciences Languages:
? English and other major languages preferred
Experience/Professional Requirement:
? Minimum of 1-2 years of applicable experience within clinical research and/or business administration
?Knowledgeofapplicableguidelines,includingGCPguidelines,ICHandFDAregulations
