UNC
Quality Assurance & Regulatory Specialist
UNC, Chapel Hill, North Carolina, United States, 27517
Overview
Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. This position's work location is designated as hybrid and, please note, the designated work location is subject to change based on the unit's business needs. Responsibilities
The Quality Assurance & Regulatory Specialist will be responsible for supporting Research Coordination & Management Unit (RCMU) clients by monitoring investigator-initiated trials across the UNC research enterprise. This position will also support the integrity, compliance, and quality of research conducted by the RCMU by developing, implementing, and maintaining quality assurance processes. The Quality Assurance & Regulatory Specialist plays a key role in ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical Practice (GCP) standards. The selected candidate will serve as a resource for regulatory compliance, study documentation review, and best practice development contributing to a culture of continuous improvement and research excellence.
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Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. This position's work location is designated as hybrid and, please note, the designated work location is subject to change based on the unit's business needs. Responsibilities
The Quality Assurance & Regulatory Specialist will be responsible for supporting Research Coordination & Management Unit (RCMU) clients by monitoring investigator-initiated trials across the UNC research enterprise. This position will also support the integrity, compliance, and quality of research conducted by the RCMU by developing, implementing, and maintaining quality assurance processes. The Quality Assurance & Regulatory Specialist plays a key role in ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical Practice (GCP) standards. The selected candidate will serve as a resource for regulatory compliance, study documentation review, and best practice development contributing to a culture of continuous improvement and research excellence.
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