FSP Clinical Trial Coordinator I

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

📋 Description

• Oversee, coordinate, and finalize assigned trial activities in accordance with the task matrix.

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

• Ensure that assigned tasks are completed punctually, within budget, and to a high standard of quality.

• Provide system support for Activate and eTMF while keeping databases up-to-date.

• Manage documents for Client eTMF, carry out eTMF reviews, disseminate communications, and prepare reports.

• Analyze and reconcile findings reports and study metrics.

• Coordinate materials for the Investigator Site File, Pharmacy binder, and non-clinical study supplies.

• Support the production of study-specific translation materials and oversee translation quality control.

• Conduct on-site feasibility assessments as needed in the Asia Pacific region.

• Assist with scheduling for client and internal meetings.

• Review and monitor local regulatory documentation.

• Support risk-based monitoring initiatives.

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

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers up-to-date.

• Assist with regulatory submissions and the preparation of regulatory compliance review packages.

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

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

• Complete Site Interest Plans and gather relevant investigator and site personnel documents.

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

• Review survey data for logical coherence, completeness, and relevance.

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

• Escalate concerns and any instances of non-compliance to management.

• Provide local expertise on site capacity, experience, and tiering.

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

• Contribute to global feasibility processes and the establishment of best practices.

• Train new staff in processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• A Bachelor's degree is preferred.

• Previous experience of approximately 0 to 1 year is desirable.

• Equivalence through a combination of suitable education, training, and/or directly related experience may be acceptable.

• Capacity to work both independently and as part of a team.

• Strong organizational skills and great attention to detail.

• Ability to accurately and efficiently analyze project-specific data/systems.

• Strong focus on customer service.

• Flexibility to adjust workload priorities as needed.

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

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

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

• Ability to learn and master clinical trial database systems.

• Capability to complete the organization’s clinical training program.

• Effective oral and written communication abilities.

• Essential judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Good negotiation skills.

• Capacity to manage risk and perform appropriate risk escalation.

• Occasional travel may be necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.