Carolina Population Center · 3 weeks ago
Quality Assurance & Regulatory Specialist
North Carolina, US
Full-time
Hybrid
Mid, Senior Level
$70K/yr - $85K/yr
2+ years expThe University of North Carolina at Chapel Hill is a global leader in higher education known for its commitment to research and public service. The Quality Assurance & Regulatory Specialist will support research coordination and management by ensuring compliance with institutional policies and federal regulations while developing quality assurance processes for investigator-initiated trials.
Higher Education
Responsibilities
Monitoring investigator-initiated trials across the UNC research enterprise
Supporting the integrity, compliance, and quality of research conducted by the RCMU
Developing, implementing, and maintaining quality assurance processes
Ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical Practice (GCP) standards
Serving as a resource for regulatory compliance, study documentation review, and best practice development
Qualification
Required
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution
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
Preferred
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
Benefits
Comprehensive benefits package
Paid leave
Variety of health, life and retirement plans
Additional programs that support a healthy work/life balance
Professional training opportunities for career growth, skill development and lifelong learning
Exclusive perks for numerous retail, restaurant and performing arts discounts
Savings on local child care centers
Special rates on select campus events
Company
Carolina Population Center
The Carolina Population Center (CPC) is a community of outstanding scholars and professionals associated to create new knowledge about population size, structure, and processes of change.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase