Clinical Research Regulatory Coordinator- 225565
2 weeks ago
Overview: The Clinical Research Regulatory Coordinator plays a vital role in ensuring compliance with regulatory requirements and guidelines governing clinical research studies. This position involves liaising with regulatory authorities, preparing and submitting documentation, and maintaining accurate records to facilitate the smooth operation of clinical trials.
Responsibilities:
- Regulatory Compliance: Ensure adherence to regulatory requirements set forth by governing bodies such as the FDA, ICH-GCP, and institutional review boards (IRBs).
- Documentation Preparation: Prepare, review, and submit regulatory documents such as study protocols, informed consent forms, investigator brochures, and annual reports to regulatory agencies and IRBs.
- Study Start-Up: Facilitate the initiation of clinical trials by obtaining necessary regulatory approvals and ensuring all essential documents are in place before study commencement.
- Monitoring and Auditing: Assist in internal and external audits by maintaining accurate and organized regulatory files and providing requested documentation and information.
- Communication: Serve as a liaison between research teams, regulatory authorities, and sponsors, providing updates on regulatory requirements and ensuring timely submission of documents.
- Record Keeping: Maintain comprehensive and up-to-date regulatory files and databases, including tracking submissions, approvals, and correspondence related to each clinical trial.
- Training: Provide guidance and training to research staff on regulatory compliance and documentation requirements to ensure adherence throughout the study lifecycle.
Qualifications:
- Bachelor's degree in a relevant field such as life sciences, nursing, or pharmacy.
- Prior experience in clinical research coordination or regulatory affairs preferred.
- Strong understanding of regulatory guidelines and requirements governing clinical research studies.
- Excellent organizational skills with meticulous attention to detail.
- Effective communication and interpersonal skills to interact with diverse stakeholders.
- Ability to work independently and collaboratively in a fast-paced environment.
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