The Regulatory Coordinator is responsible for preparing, organizing, and implementing regulatory research documents in accordance with FDA guidelines and ICH GCP standards. They serve as a liaison between the site, investigators, and IRBs while ensuring all regulatory binders and staff credentials are maintained for audits.
The Contract Manager facilitates clinical trial agreement negotiations and manages site-level study budgets with sponsors and vendors. They also oversee personnel training and ensure strict adherence to regulatory guidelines such as GCP and FDA standards.
The Business Development Manager is responsible for identifying and pursuing clinical trial study opportunities with sponsors and CROs to drive company growth. They will manage strategic account activities, maintain a qualified sales pipeline, and ensure accurate reporting within the CRM system.
The QC Associate ensures the accuracy and integrity of clinical trial documentation by reviewing essential trial documents for compliance with GCP and internal SOPs. They collaborate with cross-functional teams to identify discrepancies, support audit readiness, and maintain high standards in clinical data practices.
