Clinical Trial Coordinator I/II/Senior
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Job Description
Clinical trial coordinator supporting pharmaceutical and biotech clinical trials from the Philippines. Coordinating study documentation, regulatory tracking, systems, site materials, and project activities.
Responsibilities:
- Coordinate, oversee, and complete assigned trial activities according to the task matrix
- Perform department, internal, country, and investigator file reviews and document findings
- Ensure allocated tasks are completed on time, within budget, and to a high quality standard
- Communicate project risks to project leads and line manager
- Maintain study-specific documentation, team lists, training trackers, system access management, and project activity plans
- Keep the electronic Trial Master File up to date and document review findings
- Provide system support, including GoBalto and eTMF
- Support risk-based monitoring activities
- Perform trial administration, including document processing, eTMF reviews, mass mailings, communications, and reports
- Schedule and organize client/internal meetings and complete meeting minutes
- Review and track local regulatory documents
- Transmit documents to the client and centralized IRB/IEC
- Analyze and reconcile study metrics and findings reports
- Assist with clarification and resolution of site documentation findings
- Maintain vendor trackers
- Assist with Investigator Site File and Pharmacy binder materials and study supplies for sites
- Assist with study-specific translation materials and translation quality control
- Attend kickoff meetings and take notes when required
- Provide administrative and technical support to the Project Team
- Coordinate and facilitate project activities and potentially serve as study lead and cross-functional liaison
- Act as an onboarding buddy and provide training to new staff
- Support departmental and cross-functional process improvement initiatives
Requirements:
- Bachelor's degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years)
- Equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
- Ability to work in a team or independently as required
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs
- Excellent English language and grammar skills and proficient local language skills as needed
- Good presentation skills
- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint), and ability to master clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude with effective strong interpersonal skills
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