Clinical Trial Coordinator I

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Facilitate audit preparedness through organized file reviews in line with SOPs and departmental guidelines.

• Offer administrative aid for site activation and assist in crafting site activation critical paths.

• Create and evaluate site lists for feasibility activities, contributing local insights for site tiering.

• Coordinate, manage, and execute assigned trial tasks per the task matrix.

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

• Complete assigned responsibilities punctually, within budget, and adhering to quality standards; communicate risks to project leaders.

• Assist with Activate and eTMF systems, ensuring databases are up to date.

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

• Analyze and reconcile study metrics and findings reports.

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

• Support translation materials and oversee translation quality control.

• Conduct on-site feasibility assessments as necessary across the Asia Pacific region.

• Schedule meetings for clients and internal teams.

• Review and monitor local regulatory documents.

• Assist with risk-based monitoring efforts and study documentation systems.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor tracking systems.

• Aid in regulatory submissions and prepare packages for regulatory compliance reviews.

• Collaborate with sites to gather site-selection documents.

• Coordinate with internal departments to synchronize site start-up activities with the activation critical path.

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

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

• Collaborate with colleagues and clinical staff to resolve site-related issues and risks.

• Raise concerns and non-compliance issues to management.

• Provide local insights on site capacity and experience, recommending additional sites as needed.

• Liaise with Global Investigator Services to address investigator inquiries 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

• Bachelor's Degree is preferred.

• Approximately 3 years of clinical research experience is preferred.

• Excellent verbal and written communication skills.

• Practical, hands-on experience with eTMF systems, particularly Veeva Vault.

• Experience in preparing precise meeting minutes for large, cross-functional teams.

• Capability to work collaboratively or independently as required.

• Strong organizational skills and keen attention to detail.

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

• Strong customer-oriented mindset.

• Flexibility to adjust workload priorities.

• Knowledge of relevant Country Regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

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

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

• Ability to learn and master clinical trial database systems.

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

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

• Sound judgment and decision-making abilities.

• Ability to accurately adhere to project work instructions.

• Good negotiation skills.

• Ability to manage risk and escalate issues appropriately.

• Occasional travel may be necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.