Terumo Aortic are currently recruiting for a Senior 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;
Assist the Clinical Affairs Department with Clinical Investigations 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)
- Responsible for processing and reporting of device related safety incidents in compliance with regulatory and internal procedural timelines
- Facilitate communications with the internal complaint departments and clinical study site to gather pertinent safety data for regulatory reporting as required
- Serve as primary project contact for safety reporting to ensure communication is maintained and reporting schedules are adhered to.
- Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables.
- Contribute to risk management activities, as required
- Create, circulate and file accurate meeting minutes including any action follow-up
- Review of Clinical Investigation Plan, study reports, Investigator's Brochure (IB), and other related documents
- Assist in preparation of clinical safety documents if applicable based on experience such as, safety management plan, safety reports and presentations
- Creation and Maintenance of Study Logs
- Oversee the preparation of clinical trial documentation, including Investigator Site File (ISF) preparation and shipping
- Process data requests from internal personnel and external parties
- 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
- Lead team meetings on specific projects
- Serve as a primary project contact to ensure communication is maintained and reporting schedules are adhered to.
- Aid with regulatory submissions
- Other activities as required to support Clinical Affairs Deliverables
- Implementation, set up and maintenance of Trial Master File (TMF/eTMF) including any applicable Clinical Trial Management Systems (CTMS)
- Input into design of Case Report Forms (CRFs) and participating in the validation of electronic data capture (EDC), as required
- Oversight and coordination of Vendor Management for specific projects
The successful candidate will possess;
- Clinical Trial Administration experience in a related field (Essential)
- Previous experience of managing a CTMS/eTMF (Essential)
- Advanced knowledge of Trial Master File management (Desirable)
- Previous experience of working in a medical device company (Desirable)
- Basic knowledge of GCP, ISO14155 and Medical Device Regulations (Desirable)