Tasks and responsibilities of the Clinical Research Associate
- Monitor clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines;
- Perform feasibility, site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices, applicable laws and regulations SOPs and Work Instruction;
- Escalate quality issues to Clinical Team Lead and/or Linemanager;
- Manage the progress of assigned studies to support recruitment and enrolment, CRF completion, and data query generation and resolution, essential document collection and filing study documentation;
- Train investigators and site staff in the correct implementation of the protocol and study-specific procedures and establish an effective work relationship with sites to manage ongoing project expectations and issues;
- Support the investigator during inspections by healthcare authorities or audits;
- Be involved in SOP development, maintenance and training.




