A company is looking for a Clinical Research Regulatory Coordinator II.
Key Responsibilities Facilitate initial new trial submissions for SRC and IRB review Develop the Informed Consent document with input from the trial's sponsor and Principal Investigator Maintain clinical trial regulatory documents and files during the IRB review process Required Qualifications Bachelor's Degree in Healthcare Management or a related field required 2-3 years of Regulatory Affairs experience required Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations Understanding of the clinical trial process and regulatory compliance Proficiency in using relevant software for regulatory documentation management