Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical support to the Project Team.

• Assist in audit preparedness through regular file reviews in line with SOPs and departmental guidance.

• Offer administrative assistance for site activation initiatives and aid in the formulation of critical paths for site activation.

• Create and evaluate site listings for feasibility tasks and provide local insights for site tiering.

• Organize, supervise, and fulfill assigned trial tasks as per the task matrix.

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

• Ensure that assigned responsibilities are completed punctually, within budget, and meet quality benchmarks.

• Provide system support for Activate and eTMF, maintaining up-to-date databases.

• Process documentation for client eTMF, conduct eTMF reviews, communicate distributions, and generate reports.

• Analyze and reconcile study metrics and findings reports.

• Coordinate and distribute Investigator Site File and Pharmacy binder materials along with non-clinical supplies.

• Assist with translation materials and ensure translation quality control.

• Conduct on-site feasibility assessments where applicable in the Asia Pacific region.

• Arrange client and internal meetings as necessary.

• Review and monitor local regulatory documents.

• Facilitate risk-based monitoring efforts.

• Maintain documentation related to studies, team lists, training requirements, system access, and activity plans.

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers updated.

• Assist with regulatory submissions and prepare packages for regulatory compliance reviews.

• Work directly with sites to gather site-selection documents.

• Collaborate with internal departments to synchronize site start-up actions with the activation critical path.

• Complete Site Interest Plans in CTMS and collect necessary investigator and site personnel documentation.

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

• Assess survey data for logical completeness and relevance.

• Partner with teammates and clinical staff regarding site challenges and risks.

• Maintain site contact and follow-up strategies, escalating any concerns or instances of non-compliance.

• Serve as a local authority on site capacity and experience, recommending additional sites as necessary.

• Collaborate with Global Investigator Services to address investigator inquiries and manage account/contact details.

• Contribute to global feasibility procedures and best practices.

• Mentor new personnel in processes and systems.

• Utilize local insights to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Previous experience ranging from 0 to 1 year is comparable.

• Equivalence may be considered through a mix of relevant education, training, and/or directly related experience.

• Capacity to work both in a team setting and independently.

• Strong organizational skills with a keen attention to detail.

• Ability to manage multiple tasks efficiently and effectively.

• Proficient in analyzing project-specific data and systems accurately.

• Strong customer service orientation.

• Flexibility to adjust workload priorities as needed.

• Familiarity with applicable country regulations, ICH Good Clinical Practices, as well as organization/client SOPs and WPDs.

• Proficient English language and grammar skills, as well as competent local language skills as required.

• Skilled in MS Office (Word, Excel, and PowerPoint).

• Capability to learn and master clinical trial database systems.

• Ability to successfully complete the organization's clinical training program.

• Strong oral and written communication abilities.

• Essential judgment and decision-making capabilities.

• Aptitude for accurately following project work instructions.

• Good negotiation skills.

• Competence in managing risk and appropriately escalating issues.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.

• Potential for occasional travel.

• Clinical training program.

• Opportunity to serve as a buddy during onboarding and provide training to new staff.