Terumo Aortic are currently recruiting for a Clinical Research Assistant to join their busy Clinical Affairs department. The successful candidate will support the Clinical Affairs Department in maintaining clinical trials and Post Market Clinical Follow-up (PMCF) Registries and Investigations/Studies. This role involves performing administrative tasks, assisting in clinical investigations, and ensuring compliance with regulatory standards. The ideal candidate will contribute to specific project elements and aid in achieving department deliverables.

Key Duties;

1. Clinical Trials and PMCF Support:

• Assist in the maintenance and management of clinical trials and PMCF registries.
• Support defined elements of clinical investigation/study projects.
• Ensure adherence to ICH GCP, Medical Device Regulation, ISO 14155, and other regulatory requirements.

2. Administrative Tasks:

• Perform various administrative duties within the Clinical Affairs Department as required.
• Maintain department files and documentation.
• Implement and maintain the Trial Master File (TMF/eTMF) and any applicable Clinical Trial Management Systems (CTMS).

3. Compliance and Training:

• Undertake training to develop and maintain competency in regulatory compliance.
• Create, develop, and maintain departmental Standard Operating Procedures (SOPs).

4. Clinical Studies Management:

• Create, circulate, and accurately file meeting minutes and ensure follow-up on action items.
• Process incoming adverse event reports from PMCF or studies.
• Assist in preparing clinical trial documentation, including Investigator Site File (ISF) preparation and shipping.
• Process data requests from internal personnel and external parties.

5. Project and Regulatory Support:

• Lead team meetings on specific projects and serve as the primary project contact.
• Aid with regulatory submissions and ensure compliance with relevant regulatory standards.
• Prepare and present internal and external presentations.
• Provide input for clinical evaluation reports (CERs).

6. Continuous Improvement:

• Undertake necessary training to enhance job performance.
• Input into the design of Case Report Forms (CRFs) and participate in their development.

Qualifications & Experience;

Essential:

• Administrative experience in a related field.
• Strong organizational and communication skills.
• Ability to work independently and collaboratively in a team environment.

Desirable:

• Previous experience working in a medical device company.
• Basic knowledge of Good Clinical Practice (GCP), ISO 14155, and Medical Device Regulations (MDR).