Sample interview questions: Can you describe your experience in obtaining necessary approvals and permits for conducting clinical research?
Sample answer:
Obtaining Approvals and Permits for Clinical Research
As a Clinical Research Coordinator with extensive experience in navigating the complexities of research ethics and regulations, I have a proven track record of obtaining necessary approvals and permits to facilitate clinical research projects.
My responsibilities involve:
- Institutional Review Board (IRB) Approval:
- Collaborating with research teams to ensure compliance with IRB guidelines and protocols.
- Preparing and submitting IRB applications that clearly outline the research plan, potential risks and benefits, and informed consent procedures.
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Managing the IRB review process, addressing any queries, and obtaining final approval.
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Health Authority Approvals:
- Identifying and obtaining relevant health authority approvals, such as investigational new drug (IND) or investigational device exemption (IDE) approvals from the Food and Drug Administration (FDA).
- Coordinating with the health authority to ensure submission of required documentation, including preclinical data, clinical trial protocols, and informed consent forms.
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Liaising with regulatory inspectors to facilitate the review process and address compliance issue… Read full answer
Source: https://hireabo.com/job/7_0_31/Clinical%20Research%20Coordinator