Job Description
Job Description
Insight Global is seeking a Regulatory Specialist to join the Clinical Research team at Hackensack Meridian Health in Hackensack, NJ. This contract role will support compliance and regulatory operations for clinical trials, ensuring adherence to institutional, federal, and sponsor requirements. The Regulatory Specialist will be responsible for preparing, submitting, and maintaining regulatory documents such as IRB submissions, amendments, and continuing reviews, while ensuring compliance with FDA, ICH-GCP, and institutional policies. Additional duties include maintaining accurate regulatory files, tracking essential documents in CTMS, and communicating with sponsors, CROs, and internal stakeholders regarding regulatory requirements. The role also involves assisting with audits and inspections, implementing corrective actions, and supporting protocol activation and ongoing trial maintenance. Candidates should have a bachelor’s degree in life sciences or a related fiel...
Insight Global is seeking a Regulatory Specialist to join the Clinical Research team at Hackensack Meridian Health in Hackensack, NJ. This contract role will support compliance and regulatory operations for clinical trials, ensuring adherence to institutional, federal, and sponsor requirements. The Regulatory Specialist will be responsible for preparing, submitting, and maintaining regulatory documents such as IRB submissions, amendments, and continuing reviews, while ensuring compliance with FDA, ICH-GCP, and institutional policies. Additional duties include maintaining accurate regulatory files, tracking essential documents in CTMS, and communicating with sponsors, CROs, and internal stakeholders regarding regulatory requirements. The role also involves assisting with audits and inspections, implementing corrective actions, and supporting protocol activation and ongoing trial maintenance. Candidates should have a bachelor’s degree in life sciences or a related fiel...