Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team while serving as a study lead and cross-functional liaison.

• Organize and facilitate project activities, ensuring effective administration on assigned projects.

• Act as a mentor during onboarding and provide training to new team members.

• Recognize and identify new training needs.

• Assist in process improvements, enhancements, implementation, and change management initiatives.

• Help develop the critical path for site activation and serve as an escalation point for the project team.

• Coordinate, manage, and execute assigned trial activities in accordance with the task matrix.

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

• Ensure timely completion of tasks within budget and quality standards; communicate potential risks.

• Maintain study documentation, team lists, training trackers, system access, activity plans, and eTMF records.

• Support risk-based monitoring activities.

• Process documents, conduct eTMF reviews, manage communications, and generate reports.

• Schedule client/internal meetings and document meeting minutes.

• Review and monitor local regulatory documents, aiding in audit preparedness and responses.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings; address site-documentation issues.

• Maintain vendor trackers and coordinate Investigator Site Files, pharmacy binders, and study-supply materials.

• Assist with translation materials and ensure translation quality control.

• Provide system support and keep clinical-trial databases updated.

• Liaise locally on submission activities according to global strategy.

• Maintain accurate trial-status information.

• Build and maintain client-affiliate relationships when applicable.

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

• Train personnel, functional team members, investigators, and clients as requested.

• Serve as a lead for client integration and eTMF activities at the alliance level.

• Facilitate site activation through technical/administrative coordination, site agreements, budgets, essential documents, regulatory packages, and site communications.

• Develop site lists and keep investigator/site staff contact details up to date.

• Complete Site Interest Plans in CTMS and document site communications and survey responses.

• Review survey data and collaborate to achieve response targets.

• Plan and follow up on site contacts, escalating concerns or compliance issues as necessary.

• Act as a local expert on site capacity and experience, recommending suitable sites.

• Conduct interviews with physicians and site personnel to gather protocol-level insights.

• Resolve investigator inquiries and maintain account/contact information.

• Contribute to global feasibility processes, best practices, and strategic feasibility initiatives.

• Identify and cultivate new sites utilizing local market knowledge.

• Act as a subject matter expert on feasibility survey tools and contribute to future system enhancements.

⛳️ Requirements

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

• Prior experience providing the necessary knowledge, skills, and abilities for the role, equivalent to at least 6 years.

• Bachelor's degree is preferred.

• Capability to work effectively in a team or independently as needed.

• Exceptional organizational skills and a keen attention to detail.

• Proficient in managing multiple tasks efficiently and effectively.

• Ability to analyze project-specific data/systems for accuracy and efficiency.

• Flexibility and adaptability to reprioritize workload and meet changing project timelines.

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

• Excellent English language and grammar skills, with proficient local language skills as required.

• Strong presentation abilities.

• Proficiency 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 interpersonal, oral and written communication, problem-solving, negotiation, and customer-focused skills.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Basic knowledge of local health systems.

• Ability to navigate a matrix environment.

• Competence in managing risk and appropriately escalating issues.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.