Clinical Trial Coordinator

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

📋 Description

• Offer administrative and technical assistance to the Project Team.

• Facilitate audit preparedness by performing scheduled document reviews in accordance with SOPs and departmental guidance.

• Assist in site activation efforts and the formulation of site activation critical paths.

• Create and assess site lists for feasibility tasks and provide local insights for site tiering.

• Manage, supervise, and execute assigned trial tasks as outlined in task matrices.

• Conduct reviews of departmental, internal, country, and investigator files and document observations.

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

• Support Activate and eTMF systems while ensuring databases are up to date.

• Process and review eTMF documents, distribute communications, and supply documents and reports.

• Analyze and reconcile study metrics and findings reports.

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

• Assist in the translation of 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.

• Ensure study documentation, team lists, training requirements, system access, and activity plans are maintained.

• Send documents to clients and centralized IRB/IEC.

• Maintain vendor tracking systems.

• Support regulatory submissions and prepare packages for regulatory compliance reviews.

• Collaborate with sites to obtain necessary site-selection documents.

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

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

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

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

• Partner with team members and clinical staff to meet deadlines and address site-related issues and risks.

• Manage site contact and follow-up strategies and escalate concerns or non-compliance as needed.

• Provide local insights on site capacity and experience and suggest additional sites as necessary.

• 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 on processes and systems.

• Utilize local expertise to identify and develop new study sites.

⛳️ Requirements

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

• Prior experience that equips the candidate with the necessary knowledge, skills, and abilities for the role, typically ranging from 0 to 1 year.

• Bachelor’s degree is preferred.

• Capability to work collaboratively in a team or independently.

• Strong organizational abilities and meticulous attention to detail.

• Proficiency in handling multiple tasks efficiently and effectively.

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

• Strong focus on customer service.

• Flexibility to adjust workload priorities as required.

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

• Proficient in English and capable of utilizing local language skills as needed.

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

• Willingness to learn and master clinical trial database systems.

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

• Effective verbal and written communication abilities.

• Strong judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Good negotiation skills.

• Capacity to manage risk and escalate issues appropriately.

• Occasional travel to site locations may be necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Comprehensive training and onboarding support.

• Opportunity to serve as a buddy and mentor for new staff.

• Potential for professional development through the clinical training program.