Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Contribute to audit readiness by evaluating files in accordance with SOP schedules and departmental guidelines.

• Offer administrative support for site activation processes.

• Assist in the development of critical paths for site activation.

• Create and assess site lists for feasibility activities, providing local insights into site tiering.

• Coordinate, supervise, and finalize assigned trial activities as outlined in the task matrix.

• Conduct reviews of departmental, internal, country, and investigator files, documenting findings.

• Complete assigned tasks punctually, within budget, and meeting quality standards; communicate risks to project leads.

• Support Activate and eTMF systems while ensuring databases are up to date.

• Process documents sent to the client eTMF, conduct eTMF reviews, disseminate communications, and provide documents and reports.

• Analyze and reconcile study metrics and findings reports.

• Assist with materials for the Investigator Site File and Pharmacy binder, non-clinical supplies, and site distribution.

• Facilitate study-specific translation materials and oversee translation quality control.

• Conduct on-site feasibility visits when applicable in the Asia Pacific region.

• Assist in scheduling client and internal meetings.

• Review and monitor local regulatory documents.

• Support risk-based monitoring initiatives.

• Maintain study documentation and systems, including team lists, training requirements, system access, and activity plans.

• Send documents to clients and centralized IRB/IEC.

• Keep vendor trackers updated.

• Assist with regulatory submissions and prepare regulatory compliance review packages.

• Collaborate with sites to acquire site-selection documents.

• Coordinate with internal departments to synchronize site start-up activities.

• Complete Site Interest Plans and gather related investigator/site documents.

• Record site communications, follow-ups, and survey responses in real-time.

• Evaluate survey data for logical, complete, and relevant responses.

• Work together with teammates and clinical personnel on site issues and risks.

• Ensure implementation of site-contact plans and escalate any concerns or compliance issues.

• Provide local expertise regarding site capacity and experience, suggesting additional sites as needed.

• Coordinate with Global Investigator Services to address investigator queries and maintain account/contact information.

• Contribute to global feasibility processes and best practices.

• Train new team members in processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

⛳️ Requirements

• High/Secondary school diploma or equivalent along with relevant formal academic/vocational qualifications.

• Bachelor's degree is preferred.

• Prior experience ranging from 0 to 1 year is desirable.

• Capability to work collaboratively or independently as necessary.

• Strong organizational skills and keen attention to detail.

• Proficiency in managing multiple tasks efficiently and effectively.

• Aptitude for accurately and efficiently analyzing project-specific data/systems.

• Strong customer-centric approach.

• Flexibility to adjust priorities to accommodate shifting project timelines.

• Familiarity with relevant country regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs.

• Proficient in English language and grammar, with necessary local language skills.

• Competent computer skills; proficiency in MS Office (Word, Excel, and PowerPoint).

• Ability to learn and master clinical trial database systems.

• Capable of successfully completing the organization’s clinical training program.

• Self-motivated with a positive attitude and strong interpersonal skills.

• Effective oral and written communication abilities.

• Strong judgment and decision-making capabilities.

• Skill in accurately following project work instructions.

• Good negotiation skills.

• Independent thinking abilities.

• Competence in managing risk and performing appropriate risk escalation.

• Potential for occasional travel may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.