Tuesday, June 21, 2011

Job : Clinical Research Coordinator - Religare SRL Diagnostics

Company Name : Religare SRL Diagnostics
Qualification      : M.Sc. Biotechnology
Location             : Mumbai
Experience         : 0 - 1 Year
Job Description :
 Project Set up *Ensure project set up in accordance with the Study Protocol, Sponsor time frame for each contracted study & in compliance with all SOP's pertinent to the project set-up process.

*Following the timelines provided by the PE & the sponsor for completion of project setup prior to FPFV at SRL.

*Designing Lab. Manual, Customized TRF, Kits & Test SOPs prior to study initiation. 

*Ensuring setup of Study Master to include of study related details pertaining to the protocol. 

*Setting up of logistics prior to study initiation. 
*Ensure 100% compliance of all relevant SOP's pertinent to the project set-up process without any deviations 

*Telephonic Site initiation to confirm the receipt of the start up kit

PROJECT CLOSE OUT & DATA LOCK *Ensure that Sponsor time lines for a data lock are met 100%. Also ensuring a smooth project closeout with project related documents & correspondence filed appropriately
*Ensuring amendment of lab records to meet the data lock requirement.
Ensuring that all study related documents are maintained in the respective study file & submit to the PE for QC.
*Ensure 100% compliance of all pertinent SOP's for this process without any deviations.
*After receiving the study close out/data lock intimation from the Sponsor and QC from the PE  forward the project files for Archival

*Interfacing with internal departments, PE & CRS-OM in resolving queries raised by site/sponsor in real time
*Addressing of issues & unanswered queries raised by site / sponsor. 
*On-going Support the PE, Fellow team members & CRS-OM for the smooth execution of the project & to build a strong CRS team

*Proactively assisting fellow team members & PE for the smooth execution of the project.
 Candidate can mail their mentioning the Position / Locations in subject column to rachna@srl.in For original notification  Click Here

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