SRL Limited, Delhi
Company Web Address : http://www.srlworld.com

Clinical Research Services - Clinical Research coordinator
Qualification : M.Sc ( Bio Technology)
Experience : 0 - 1 Year
Location : Mumbai
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 MANAGEMENT - PRODUCTION PHASE
** 100% implementation of all relevant SOP's & processes related to the production phase of the assigned studies & there by ensuring 100% sponsor & investigator satisfaction & 0% project management related issues.
** Completing all Daily tasks (TRF checking, maintaining specimen status & report checking.
** Initiating weekly Site Co-ordination & taking necessary actions on inputs received.
** Follow-up for pending tasks & activities.
** 100% Implementation of all related SOP's to ensure no deviations.
** Maintainance and Updation of study related documents.

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

ADDRESSING QUERIES
** 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.

TEAM SUPPORT
** 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.

Desired Candidate Profile :
Candidate should have completed Msc. Bio Technology with a relevant experience of 1 year.
Coordination Skills :Team Player

Clinical Research Services - Data Management Officer
Qualification : M.Sc in Life Sciences with relevant experience
Experience : 0 - 1 Year
Location : Mumbai
Job Description :
DATABASE SET UP As per defined internal time frames taking into consideration the sponsors time frame for initiation of the study.
** The Laboratory Technologist performs his duties diligently and methodically to analyse specimens allotted to him / her. These specimens are analyzed as per procedure for the test approved by the Executive Director - Operations.
** Ensure Database set up in accordance with the study protocol, Electronic Data Transfer
** specifications, sponsor time frame for each contracted study and in compliance with all SOPs
** pertinent to the data set up process.
** Following the time lines provided by the DME and the sponsor for completion of the database set up prior to FPFV at SRL.
** Building the test SOPs in the database prior to study initiation.
** Update of Recipe cost for each new test SOP/Code built in the LIS system. Ensuring the set up of Study Masters to include the Study related details pertaining to the protocols.

Kindly mail your resume mentioning the Position / Locations in subject column to careers@srl.in

Contact Us:
SRL Limited
Plot No. D-3, District Centre,
A- wing, 2nd Floor, Saket
New Delhi - 16