Clinical Research Associate
An exciting clinical opportunity has arisen for a Clinical Research Associate (CRA) to work from Taiwan. You will be working fully embedded within one of our pharmaceutical clients, you'll be at the heart of our client's innovation.
- Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
- Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned.
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.
- Experience working on Oncology trials or complex studies would be an advantage for this role.
- Study start up experience (Feasibility, Contract Negotiation, submissions) preferred.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.