Clinical Research Assistant

2 weeks ago

Renfrew, United Kingdom Terumo Aortic Full time

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
- 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
- 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)
- 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

**Job Type**: Fixed term contract
Contract length: 12 months

**Benefits**:

- Additional leave
- Casual dress
- Cycle to work scheme
- Discounted or free food
- Free parking
- Life insurance
- On-site parking
- Referral programme
- Sick pay
- Work from home

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus scheme

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