Job Details

A company is looking for a Regulatory Coordinator who will support the regulatory and compliance processes of clinical research.Key ResponsibilitiesPrepare and submit protocols and supporting documents to regulatory bodies and agenciesRespond to inquiries from sponsors, institutional departments, and regulatory bodiesMaintain research files and documentation in compliance with regulatory requirementsRequired Qualifications, Training, and Education1 year of experience in healthcare, clinical research, or a related fieldBachelor's Degree in a related field or equivalent combination of education and experienceExperience in clinical research compliance and/or regulatory research is preferredKnowledge of FDA regulations and ICH and GCP guidelines is preferredExperience using electronic data submission software is preferred