Clinical Research Assistant - Renfrew, United Kingdom - Terumo Aortic

Terumo Aortic

Verified Company

Renfrew, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 followup
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
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)