Contractor CRA_Poland

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.