Terumo Aortic are currently looking to recruit a Clinical Research Assistant on a FTC for 6 months. 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)