Clinical Supply Integrator Coordinator

Job Description:
The Clinical Supply Integrator Coordinator (CSIC) will work closely with the CSI team to perform the following tasks:
1. Prepare and coordinate review and approval of Distribution Plans for all new Clinical Trials.
a. Proactively request new clinical trials to be added to Distribution database
b. Create Distribution Plan, coordinate review meetings with depots/CSIs, make updates to plan and route for approvals, review distribution quotes and prepare for CSI review, route final quotes for approval and initiate PO process. Communicate PO numbers to all depots and ensure all approved versions of Distribution Plans are posted in appropriate repository.
2. Coordinate 3rd Party Requests
a. Obtain SMPC and post in appropriate repository
b. Create requests for technical documents on CSI Sharepoint site follow up with expert team to ensure timely completion
c. Ensure Sharepoint site is kept up to date with TD numbers as well as status
d. Manage Sharepoint for changes as needed
3. Single Point of Contact for Quality Events for CSI team
a. Attend weekly quality meetings to provide updates on CSI owned records
b. Follow up with CSI team (as needed) to ensure timely completion of records
c. Once trained, act as SPOC for all records for CSI (Open, pre-populate, manage) and then work with impacted CSI to add issue specific content
4. Develop system to manage processes within CSI team:
a. Track upcoming periodic review and notify team
b. Routing updates to WIs/SOPs through docspace and gaining approvals
c. Create standard set of training material to be used across CSI team for all process updates.
5. Assist with management of the following items on behalf of the CSI team:
a. Obtaining release documents/bulk lot information for filings/CSRs
b. Sample shipment tracking for development work.
c. CSI Sharepoint maintenance/changes/enhancements
6. Perform Quality Review in vTMF
7. Complete Temperature Intake Form on behalf of CSI

Thanks!!

With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x 219

Inc. 5000 – 2007-2015 (9 Years in a row)