Terumo Aortic are currently recruiting for Clinical Research Assistant to join our Clinical Affairs team during an exciting phase of investment and expansion within the business. This is an excellent opportunity to develop your career whilst making a real difference.
The main responsibilities of the role are;
General Duties
- Work in compliance with ICH GCP, the Medical Device Regulation, ISO 14155, internal procedural documents and any other relevant regulatory requirements
- Undertake training to develop competency in compliance with ICH, GCP, the Medical Device Regulations (MDR), ISO 14155, internal procedural documents and any other relevant regulatory requirements
- Create, develop, and maintain departmental Standard Operating Procedures (SOPs)
- Processing of Study related finance activities (invoice processing and tracking)
Clinical Studies
- Create, circulate and file accurate meeting minutes including any action follow-up
- Process incoming adverse event reports from PMCF or studies
- Assist in the preparation of clinical trial documentation, including Investigator Site File (ISF) preparation and shipping
- Process data requests from internal personnel and external parties
- Perform other administrative duties as required within the department
- Undertake any necessary training to enhance job performance
- Prepare and present internal and external presentations
- Lead team meetings on specific projects
The Successful candidate will possess;
- Administrative experience in a related field (Essential)
- Experience in working with a CTMS and eTMF (Desirable)
- Previous experience of working in a medical device company (Desirable)
- Basic knowledge of GCP, ISO14155 and Medical Device Regulations (Desirable)