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3 days ago
The Regulatory Compliance Specialist - Clinical Trials position is responsible for ensuring compliance with applicable regulations and guidelines in the conduct of clinical trials. This role requires strong knowledge of clinical research regulatory requirements and the ability to apply this knowledge in a practical setting.
Key Responsibilities:
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Collaborate with sites to develop and implement strategies to enhance subject recruitment and retention.
- Administer protocol and related study training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.
- Ensure that site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
- Collaborate and liaise with study team members for project execution support as necessary.
- If applicable, may be accountable for supporting development of project subject recruitment plans on a per-site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreements and retrieving invoices according to local requirements.
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