Clinical Trial Associate II

As a Clinical Trial Associate II, you will play a key role in ensuring clinical trial documentation is maintained efficiently and complies with regulatory standards. Key Responsibilities: Document Management Maintain Trial Master File (TMF)/eTMF in compliance with SOPs and regulatory requirements. Review site documents for accuracy and completeness (ALCOAC standards). Perform quality checks on eTMF sections and resolve discrepancies. Assist with essential document collection during study startup, maintenance, and close-out. Support translation of site documents (if required). Data Entry, Tracking, and Reporting Assist with CTMS setup and data entry (site updates, activation tracking). Track Investigator's Brochure, safety reports, and site communications. Manage system access (CTMS, EDC, IWRS) for site staff and clinical teams. Review training compliance for clinical teams. Additional Duties Attend internal meetings and assist with follow-ups. Support vendor coordination (study equipment, translations). Assist in study material development (Investigator Site Files, pharmacy binders). Mentor junior CTAs and participate in departmental initiatives.

Premier Research is a leading clinical research organization (CRO) dedicated to helping biotech, medtech, and specialty pharma companies bring life-changing therapies to patients. Their work is crucial in transforming breakthrough science into innovative medicines, devices, and diagnostics.