Ref #: 33556

Employment type: Permanent - Full-Time

Location: Lithuania

Posted: 05-Nov-2021


Clinical Research Associate II (CRA II / Field Monitor)

If you are a CRA with oncology commercial clinical trials and like travelling, this role is for you. Come and progress your career to CRA II level with a Top Pharma with reduced weekly monitoring visits!

Study Planning
• Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
• Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators.
• Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
• Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure adherence to payment schedule.
Study Start-up
• Execute site initiation and training, generate initiation visit report.
Study Execution
• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.

• Identify problems at sites; resolve issues and escalate as appropriate.
• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
• Complete preparation and generation of visit monitoring reports as per relevant SOP
• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
• If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
Study Close-out
• Implement site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection
• Improve skills by timely completion performance of assigned global and local training.

What is required
-Ideally a minimum of 2 to 4 years prior monitoring experience with global trials, as a CRA, would be preferred
-A BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
-Prior experience of working on Oncology studies and / or working on complex indications/studies would be highly desirable.
- Able to travel to sites based in Slovakia

What is offered
• Permanent full-time contract of employment with DOCS seconded to the client
• Fully home-based
• Competitive salary depending on level of skills and experience;
• Company benefits: including car allowance, pension and healthcare.

Why Join DOCS?
If you can demonstrate experience as a CRA gained at a CRO, pharmaceutical or biotech , please send* your CV today to find out more details.

*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

For more information, please contact me at