Senior Clinical Research Associate
Proclinical is excited to announce a new vacancy for a home-based Senior CRA role in Taiwan. This is a great chance to join a passionate, innovative and committed team and make some positive contributions to medicine.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Assesses site processes, Conducts Source Document Review of appropriate site source documents and medical records
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
Skills and Requirements
- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment is essential.
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
- You will be educated to degree level in a life science discipline or be a licensed healthcare professional.
Please click on the Apply button.