A company is looking for a Senior Regulatory Research Coordinator dedicated to supporting a complex portfolio of investigator-initiated trials. Key Responsibilities Serve as the primary regulatory contact for assigned protocols Maintain electronic regulatory binders/files and ensure appropriate version control Coordinate submissions to ancillary committees and communicate with the IRB and sponsors regarding regulatory management Required Qualifications High school diploma with 6 years of clinical research experience and SOCRA Certification, or a Bachelor's degree with 2 years of clinical research experience, or a Master's degree with 1 year of clinical research experience Experience working with grant-funded and Investigator-Initiated clinical trials Knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines, and HIPAA regulations related to clinical trials Familiarity with clinical research terminology and processes Experience with clinical trial management systems, such as OnCore and ClinicalTrials.gov

&#160;regarding regulatory management Required Qualifications High school diploma with 6 years of clinical research experience and SOCRA Certification, or a Bachelor&#39;s degree with 2 years of clinical research experience, or a Master&#39;s degree with 1 year of clinical research experience Experience working with grant-funded and Investigator-Initiated clinical trials Knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines, and HIPAA regulations related to clinical trials Familiarity with clinical research terminology and processes Experience with clinical trial management systems, such as OnCore and ClinicalTrials.gov

Senior Regulatory Research Coordinator

Behavioral Health Market Context

Job Description