Clinical Study Administrator – CTA

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Assist in the coordination and administration of clinical studies from initiation through execution and closeout.

• Act as the primary local administrative contact while collaborating with CRAs and/or the Local Study Associate Director.

• Establish, populate, and manage client tracking and communication systems, including CTMS, VCV, and SharePoint.

• Organize and monitor study materials and equipment.

• Handle administrative responsibilities during studies, audits, and regulatory inspections.

• Lead logistical arrangements and aid in the preparation of internal and external meetings.

• Communicate with internal and external participants and vendors.

• Prepare, contribute to, and disseminate presentation materials for meetings, newsletters, and websites.

• Collaborate with investigators, external service providers, CRAs, data management, and global clinical solutions representatives.

• Maintain the local electronic Trial Master File and Investigator Site File, ensuring proper document tracking.

• Upload critical documents in a timely manner to ensure eTMF inspection readiness.

• Prepare study documents for final archiving and assist with CRA closeout activities.

• Create and manage study documents while adhering to template and version compliance.

• Oversee document layout, language control, copying, printing, distribution, and email archiving.

• Collect, prepare, review, and monitor documents for regulatory applications.

• Assist in submissions to EC/IRB and Regulatory Authorities.

• Create or import clinical-regulatory documents into global electronic management systems.

• Support electronic applications and submissions in accordance with Submission Ready Standards.

• Prepare or assist with site-level contracts.

• Prepare, support, or execute HCO/HCP payments in compliance with local regulations.

⛳️ Requirements

• Familiarity with ICH-GCP and local regulations.

• Proficient in using clinical trial management systems and electronic management systems, including CTMS, SharePoint, VCV, and ANGEL.

• Capability to manage clinical-regulatory documents according to technical standards, including Submission Ready Standards (SRS).

• Ability to assist with EC/IRB and Regulatory Authority submissions.

• Skill in document collection, tracking, maintenance, archiving, and version control.

• Competence in supporting site-level contracts and HCO/HCP payments in accordance with local regulations.

• Proficiency in English and local-language translation, including spell-checking as necessary.

🏝️ Benefits

• Competitive salary and compensation package.

• Opportunities for professional development and growth.

• Collaborative and supportive work environment.

• Comprehensive health and wellness benefits.

• Flexible working hours and arrangements.