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Clinical Research Coordinator, Sr
2 months ago
At HIRANI, we seek highly skilled and motivated clinical research professionals to join our team. As a culturally aligned and ethically strong individual, you will have experience in in vitro diagnostic and/or companion in vitro diagnostic clinical study development, oversight, and management. Our company is at the forefront of cutting-edge science and engineering innovations that lead to real improvements in people's lives.
The Role:
- Lead the work of the company and project teams in the provision of specialized clinical research assistance to client companies, ensuring expectations and interests are met.
- Contribute to the formulation and implementation of the short and medium-term Key Performance Indices/Indicators that allow for measurement of success.
- Research and prepare elements of clinical regulatory submission documents on behalf of client companies, including but not limited to CTA's, Study risk determination requests, IDE submissions, IRB/REC Submissions.
- Contribute to the wider team's understanding of the clinical operations requirements for an investigational device in the set-up, management & conduct of device clinical investigations worldwide.
- Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies.
- Contribute to the preparation of global clinical research guidance documents and white papers.
- Identify & undertake continuing professional development linked to personal objectives to ensure ongoing awareness of current quality and regulatory standards.
