Job Title: Clinical Research Associate
Location: Bishopstown, Cork
Benefits:
* Competitive Salary
* Bonus
* Pension
* Healthcare
An excellent opportunity to develop your experience and career in a cutting-edge company.
About the Role:
In this role, you will be involved in designing, planning, implementing, and managing clinical research projects. Your goal will be to ensure compliance with the protocol and overall clinical objectives, as well as applicable SOPS and regulations.
Responsibilities:
1. Assist interdisciplinary team members in planning, executing, and closing pre-market and post-market clinical studies.
2. Develop and approve study-specific documents, tools, presentations, and processes.
3. Prepare ethics submissions, protocols, patient information leaflets, informed consent forms, and case report forms.
4. Maintain Trial Master Files and Investigator Site Files for multiple studies.
5. Prepare and present at Investigator meetings.
6. Participate in site qualification, study initiation, and study closure process.
7. Assist in medical device tracking and accountability.
8. Create and maintain study databases, including data entry, and review data/CRFs for accuracy and protocol compliance.
9. Track and report progress of studies to internal stakeholders.
10. Develop study reports and provide clinical reports for regulatory submissions.
11. Perform monitoring and site visits, preparing reports on site visit, data query, adverse event, and study deviation.
12. Serve as a company liaison for clinical sites, Contract Research Organizations (CROs), Site Management Organisations (SMOs), and other vendors/consultants.
13. Maintain familiarity with regulatory requirements and relevant clinical literature.
14. Maintain compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act, and other clinical study/trial regulations.
15. Carry out other clinical-related duties as required.
Requirements:
* Bachelor's degree in Science or related disciplines.
* A minimum of 4 years of experience in the medical device industry.
* Experience in pre-market and post-market clinical studies of medical devices is essential.
* Clinical certifications are desirable.
* Thorough understanding and knowledge of ISO 13485, ISO 14155, ICH GCP, US 21CFR820, and EU MDR.
* Proven track record in successfully managing projects to deadlines.
* Strong ability to manage critical projects within an interdisciplinary team.
* Excellent problem-solving and communication skills.
* Must be self-motivated, highly organized, and detail-oriented.
* Excellent oral and written communication skills.
* Ability to work as part of a cross-functional team.
* Thrives in a fast-paced and entrepreneurial environment.