Contractor CRA_Spain

Location: Gasteiz / Vitoria

Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

• Training

• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

• Finalize budget and obtain signed contract from site, prior to site initiation visit.

• 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major.
3.2 At least 8 year of CRA experience;
3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.