Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Facilitate audit preparedness through regular file evaluations in accordance with SOPs and departmental guidelines.

• Offer administrative support for activities related to site activation.

• Assist in the creation of critical paths for site activation.

• Create and review lists of sites for feasibility studies and provide localized insights for site tiering.

• Organize, manage, and execute assigned trial tasks in line with the task matrix.

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

• Complete designated assignments punctually, within budget, and to quality standards; communicate any risks.

• Provide support for Activate and eTMF systems while ensuring databases are up to date.

• Process and assess trial documents, manage mailings and communications, and generate reports.

• Analyze and reconcile study metrics along with findings reports.

• Organize materials for the Investigator Site File and Pharmacy binder, as well as study supplies.

• Assist with translation materials and ensure translation quality control.

• Aid in scheduling client/internal meetings and tracking regulatory documents.

• Support RBM activities and maintain study documentation/systems.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor tracking systems.

• Assist with regulatory submissions and prepare packages for regulatory compliance review.

• Collaborate with sites to gather site-selection documents.

• Coordinate with internal departments to align site start-up activities with activation critical paths.

• Complete Site Interest Plans and collect related investigator/site documentation as required.

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

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

• Work closely with teammates and clinical staff to address deadlines, site-related issues, and potential risks.

• Ensure implementation of site-contact and follow-up plans; escalate any concerns or instances of non-compliance.

• Provide local expertise regarding site capacity and experience, recommend additional sites, and assist with site tiering.

• Collaborate with Global Investigator Services to address investigator inquiries and maintain account/contact details.

• Contribute to global feasibility processes and best practices.

• Train new team members on processes and systems.

• Leverage local knowledge to identify and establish new sites.

⛳️ Requirements

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

• Bachelor's degree preferred.

• Previous experience providing the necessary knowledge, skills, and abilities to perform the job, typically 0 to 1 year.

• Capability to work independently or collaboratively within a team.

• Strong organizational abilities and meticulous attention to detail.

• Proficient in managing multiple tasks efficiently and effectively.

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

• Strong focus on customer satisfaction.

• Flexibility to adjust workload priorities as needed.

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

• Good command of the English language and grammar, alongside proficient local language skills as required.

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

• Ability to learn and master clinical trial database systems.

• Capable of completing the organization's clinical training program.

• Effective oral and written communication skills.

• Strong judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Negotiation skills.

• Competence in risk management and escalation.

• Occasional travel and driving to site locations may be necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.