Terumo Aortic are currently looking to recruit a Clinical Research Assistant on a FTC for 12months. This is an excellent opportunity to develop your career whilst making a real difference.
The main responsibilities of the role are;
- Assist the Clinical Affairs Department with Clinical Investigation/study and Post Market Clinical Follow Up (PMCF) activities taking responsibility for defined elements of projects.
- Work in compliance with ICH GCP, the Medical Device Regulation, ISO 14155, internal procedural documents and any other relevant regulatory requirements
- 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
- Responsibility for clinical research department input to specific CER's
- Prepare and present internal and external presentations
- Aid with regulatory submissions
- Take responsibility for ensuring compliance with relevant regulatory standards in defined work areas
- Other activities as required to support Clinical Affairs Deliverables
- Maintain department files
- Implementation, set up and maintenance of Trial Master File (TMF/eTMF) including any applicable Clinical Trial Management Systems (CTMS)
The successful candidate will possess;
- Administrative experience in a similar field
- Previous experience of working in a medical device company (Desirable)
Basic knowledge of GCP, ISO14155 and Medical Device Regulations