Regulatory Coordinator
Regulatory Coordinator
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$ 25 - 30
1 Vacancy
Job Description
The Center for Esophageal Diseases & Swallowing CEDAS at Chapel Hill is seeking a detailoriented and experienced Regulatory Coordinator to support the CGIBDs research team in managing regulatory processes for clinical trials. This parttime remote position offers flexibility while playing a vital role in ensuring compliance and efficiency in regulatory submissions eregulatory management and clinical trial oversight. Key Responsibilities: * Utilize UNC Clinical Trial Management Systems CTMS such as OnCore and other internal platforms to track and manage study details. * Oversee and maintain eregulatory systems (Veeva Site Vault) to ensure compliance with regulatory requirements. * Prepare submit and track IRB submissions across WCG IRB Advarra IRB and UNC IRB ensuring timely approvals and updates. * Manage and distribute critical study updates (e.g. protocol amendments Informed Consent Forms ICF Investigators Brochures (IB). * Serve as the regulatory liaison coordinating with the research team and sponsors to facilitate smooth study . * Ensure adherence to federal regulations institutional policies and sponsor requirements related to clinical research. * Maintain accurate and organized regulatory documentation for internal audits and external inspections.
Required Qualifications Competencies And Experience
Experience in clinical research regulatory processes including IRB submissions and eregulatory systems.
Preferred Qualifications Competencies And Experience
Familiarity with UNC CTMS (OnCore) and Veeva Site Vault strong organizational skills with attention to detail and the ability to manage multiple studies excellent written and verbal communication skills and ability to work independently in a remote setting while maintaining collaboration with research teams.
Required Experience:
Staff IC
Employment Type
Part-Time
