Responsibilities (a) Site management -

Study site selection, initiation (SIV) and clinical monitoring. -

Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. -

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. -

Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. -

Track study recruitment to ensure recruitment target is achieved in all studies. -

Conduct monitoring visit according to SDV plan and SOP;

address issues with sites and complete monitoring visit report in a timely manner coordinating. -

Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. -

Assemble site specific EC submission dossier, and ensure submission to EC.

Training -

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

Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.





Documentation -

Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files. -

Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety -

Ensure safety information is disseminated to all sites according SOP and applicable regulations. -

Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration -

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

Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system -

Update and maintain Study tools/systems in a timely manner.

3. Qualifications 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.

📌 Contractor Cra_spain (Vitoria-Gasteiz)
🏢 Tigermed
📍 Vitoria-Gasteiz