Clinical Trial Coordinator

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

📋 Description

• Provide administrative and technical assistance to project teams in the role of study lead and cross-functional liaison.

• Coordinate and facilitate project activities while managing administration for assigned projects.

• Serve as a buddy during onboarding and provide training for new staff members.

• Identify training needs and support process improvement initiatives within departments and cross-functional teams.

• Develop critical paths for site activation and act as a point of escalation for project teams.

• Coordinate, oversee, and execute assigned trial activities according to task matrices.

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

• Ensure that assigned tasks are completed punctually, within budget, and meet quality standards.

• Maintain study documentation, systems, tools, trackers, study team lists, training requirements, access management, and activity plans.

• Support risk-based monitoring initiatives.

• Process documents, perform eTMF reviews, distribute communications, and generate reports.

• Schedule and organize client/internal meetings and prepare meeting minutes.

• Review and monitor local regulatory documents, assisting with audit readiness and responses.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Maintain vendor trackers and up-to-date study databases.

• Coordinate materials for Investigator Site Files and Pharmacy binders, as well as non-clinical study supplies.

• Assist with translation materials and ensure translation quality control.

• Liaise locally on regulatory submissions in alignment with global strategy.

• Maintain accurate trial status information.

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

• Provide training to functional team members, investigators, and clients.

• Act as an alliance-level lead for client integration and eTMF activities.

• Support site activation, site agreements, budgets, essential documents, and regulatory compliance packages.

• Develop site lists, maintain investigator/site contact details, and complete Site Interest Plans in CTMS.

• Coordinate with site contacts, follow up, and review survey data to meet response goals.

• Serve as a local expert on site capacity and experience, recommending additional sites as needed.

• Conduct phone interviews with physicians and site personnel regarding standard of care and protocol input.

• Resolve investigator queries and maintain account/contact information.

• Contribute to global feasibility processes, best practices, and the identification of new sites.

• Serve as a subject matter expert on feasibility survey tools and future system releases.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• A minimum of 6 years of prior experience providing the knowledge, skills, and abilities necessary for the role.

• An equivalent combination of education, training, and/or directly related experience may also be considered.

• Ability to work independently and collaboratively within a team.

• Exceptional organizational skills and attention to detail.

• Capacity to analyze project-specific data and systems.

• Flexibility and adaptability to changing project timelines.

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

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

• Strong presentation skills.

• Proficiency in MS Office (Word, Excel, PowerPoint) and the ability to master clinical trial database systems.

• Capability 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 work effectively in a matrix environment.

• Proficient in managing risk and executing appropriate risk escalations.

🏝️ Benefits

• Fully remote work arrangement.

• Standard work schedule from Monday to Friday.

• Potential for occasional travel.

• Access to a clinical training program.

• Comprehensive training and onboarding support.