Clinical Trial Coordinator I/II/Senior

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

📋 Description

• Coordinate, manage, 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 constraints, and uphold high quality standards.

• Communicate project risks to project leads and the line manager.

• Maintain documentation specific to the study, including team lists, training trackers, system access management, and project activity plans.

• Keep the electronic Trial Master File updated and record review findings.

• Provide system support, encompassing GoBalto and eTMF.

• Assist with risk-based monitoring activities.

• Handle trial administration tasks, including document processing, eTMF reviews, mass mailings, communications, and reports.

• Schedule and organize meetings with clients/internal teams and prepare meeting minutes.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Aid in clarifying and resolving site documentation issues.

• Maintain vendor trackers.

• Assist with materials for Investigator Site Files and Pharmacy binders, as well as study supplies for sites.

• Support the creation of study-specific translation materials and ensure translation quality control.

• Attend kickoff meetings and take notes when necessary.

• Provide both administrative and technical support to the Project Team.

• Coordinate and facilitate project activities, potentially serving as the study lead and cross-functional liaison.

• Act as an onboarding buddy and offer training to new staff members.

• Support initiatives for departmental and cross-functional process improvements.

⛳️ Requirements

• Bachelor's degree is preferred.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (equivalent to at least 4 years).

• A combination of relevant education, training, and/or directly related experience may be deemed sufficient.

• Capability to work collaboratively in a team or independently as the situation demands.

• Strong organizational skills and attention to detail, with a demonstrated ability to manage multiple tasks efficiently and effectively.

• Proven competency in analyzing project-specific data/systems to ensure accuracy and efficiency.

• Strong customer-focused approach.

• Demonstrated flexibility and adaptability to reprioritize workload and efficiently support changing project timelines.

• Proven ability to acquire and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

• Excellent proficiency in English language and grammar, along with proficient local language skills as required.

• Good presentation capabilities.

• Excellent computer skills, with proficiency in MS Office (Word, Excel, and PowerPoint), and the ability to master clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

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

🏝️ Benefits

• Comprehensive health benefits package.

• Opportunities for professional development and career advancement.

• Supportive work environment with a focus on work-life balance.