Clinical Research Associate

Role Title Clinical Trial Associate

Role Summary

Initiate project Set up activities after the study award to Metropolis, this includes but not limited to; Customizing the TRF, LIM, Test Profiles, dummy reports for the parameters to be analyzed at Metropolis, Kit letters, Request for Client codes. Logistics set up for the timely receipt of specimens at Metropolis and ensuring that the project set up is complete prior to FPFV.

Working with- CT dept

What the role entails Key accountabilities/ responsibilities

• Releasing the reports within committed TATs.
• Resolving any queries from sponsor or Investigator site.
• Ensuring that the study is managed as per the SOP's and any guidelines laid down by the sponsor.
• Documentation of all Problem data, Problem specimens with the

Investigator.

• Ensure that the necessary specimen status, kit inventory tracker is

updated in a timely manner.

• Assisting the QA team during study or sponsor audits and ensuring that the necessary updated documents are presented to the auditors.
• Technical Responsibilities :

Ensuring proper project set up and management

Ensuring turnaround time for report release

Maintaining specimen status and inventory

Ensuring QC checks of all study related documents

What we are looking for in you

• Project Set up and Management Activities for Clinical Trials
• Projects or Business alliances awarded to Metropolis Mumbai
• Documentation

Role Demands travel -NO

Location- Mumbai