Clinical Operations Assistant
Job Overview
We are seeking a Clinical Operations Assistant to support our clinical trial operations. This role involves managing Case Report Forms, maintaining and updating project central files, and assisting with various administrative tasks. You will work closely with the site management team and project management teams to ensure quality and compliance in all clinical research activities.
Key Responsibilities
Project Central Files & Clinical Trial Management Systems Maintenance and Updates
- Track, scan, code, and apply naming conventions to documents; send them to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan.
- File and archive paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP).
- Photocopy, print, distribute, and retrieve documents as needed.
- Maintain basic quality check procedures to ensure accurate document maintenance.
- Track and maintain the Clinical Trial Management System (CTMS) and study-specific site trackers (Client additional request only).
- Monitor the status of systems and processes (e.g., annual reporting obligations, Site Compliance regarding Safety Information System (SIS), etc.) to ensure compliance.
Support to Local Site Management Team
- Assist with local billable administrative tasks.
- Provide quality control of central files.
- Support document collection, customization, and review for clinical trials being conducted in Japan.
- Liaise with sites and investigators on assigned projects to facilitate conduct and delivery.
- Work closely with project management teams on all assigned tasks.
Skills and Qualifications
- Fluency in Japanese (reading, writing, and speaking) at N2, N3 levels.
- Strong problem-solving skills and experience in CROs or the Life Sciences industry preferred.
- Ability to interact professionally within a client organization.
- Proven ability to prioritize multiple tasks and meet project timelines.
- Strong analytical skills and ability to make decisions autonomously.
- Effective time management to meet study needs, team objectives, and department goals.
- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing tasks and assisting others to meet study/country deliverables.
Knowledge and Experience
- Site Management experience or equivalent in clinical research, with a strong understanding of clinical trials methodology and terminology.
Education
- Educated to degree level in biological sciences, pharmacy, or other health-related disciplines preferred, or equivalent nursing qualification or other relevant experience.
