Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.
Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
Verify proper management and accountability of Investigational Product
Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
Timely delivering site documents to eTMF or paper TMF.
Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.

Bachelor’s Degree, preferably in life science or nursing; or equivalent
4 years of experience as CRA including relevant on-site monitoring experience
Able to work in a fast-paced environment with changing priorities.
Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess the understanding of Good Clinical Practice regulations, ICH guidelines.

Senior Clinical Research Associate

Key skills