Quality Assurance & Regulatory Specialist

UNC-Chapel Hill • Chapel Hill, NC

2d • Hybrid

About The Position

Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine’s Working Forward initiative. As such, this position’s work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit’s business needs. 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.

Requirements

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice ( GCP ), Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization ( ICH ) guidelines.
• At least 2 years of clinical trials experience.
• Comfort interacting with internal and external stakeholders and the ability to successfully collaborate with multidisciplinary groups of colleagues.
• Excellent customer service skills and good judgement are required.
• Ability to multitask and work independently with guidance from supervisor.
• Strong organizational and problem-solving skills.
• Must have a demonstrated ability to deliver high quality results on time and to manage competing priorities.
• Clinical trials and/or monitoring experience.
• Strong software and computer skills.

Nice To Haves

• SOCRA or ACRP certification preferred.
• At least 5 years clinical trials experience.
• At least 3 years of clinical trial monitoring or auditing experience.
• At least 2 years of UNC research experience.
• Experience in varied clinical areas.

Responsibilities

• supporting Research Coordination & Management Unit ( RCMU ) clients by monitoring investigator-initiated trials across the UNC research enterprise
• support the integrity, compliance, and quality of research conducted by the RCMU by developing, implementing, and maintaining quality assurance processes
• ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical Practice ( GCP ) standards
• serve as a resource for regulatory compliance, study documentation review, and best practice development contributing to a culture of continuous improvement and research excellence

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 11-50 employees