Demonstrates expertise in coordinating clinical trial activities, ensuring compliance with ICH Good Clinical Practices and local regulations, while maintaining high-quality standards and effective communication with stakeholders. Proficient in managing project-specific data and utilizing clinical trial database systems to support trial optimization.

Highest-signal resume keywords

Clinical Trial CoordinationICH Good Clinical PracticesRegulatory ComplianceMS Office ProficiencyData Analysis

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
Process documents sent to the client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
Review and track local regulatory documents
Analyze and reconcile study metrics and findings reports
Maintain vendor trackers
Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
Support study-specific translation materials and translation quality control
Provide technical and administrative project support in collaboration with internal departments and team members
Maintain accurate trial status information in databases
Develop and maintain relationships with client local affiliates where applicable
Conduct on-site feasibility visits where applicable (Asia Pacific only)
Train new personnel in processes and systems
Maintain study documentation, team lists, training requirements, system access, and activity plans
Provide system support for Activate and eTMF and support RBM activities
Transmit documents to clients and centralized IRB/IEC
Attend kick-off meetings and take notes when required
Schedule and organize client/internal meetings and prepare minutes
Coordinate with internal departments to align site start-up activities with the site activation critical path
Assist with regulatory compliance review packages and regulatory submissions
Obtain site-selection documents and develop site lists from internal and external sources
Maintain investigator and site staff contact details in company systems
Complete Site Interest Plans in CTMS and document site communications and follow-up
Review survey data for logical, complete, and relevant responses
Collaborate with teammates to meet project deadlines and communicate site issues and risks
Conduct phone interviews with physicians and site personnel to support trial optimization
Liaise with Global Investigator Services to resolve investigator queries
Contribute to global strategic feasibility processes and best practices

Requirements

What you’ll need

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)
Bachelor's degree preferred
Ability to work in a team or independently
Strong organizational skills and attention to detail
Ability to analyze project-specific data/systems
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
Proficiency in MS Office (Word, Excel, and PowerPoint)
Ability to learn and master clinical trial database systems
Ability to successfully complete the organization's clinical training program
Effective oral and written communication skills
Strong interpersonal, presentation, negotiation, organizational, and planning skills
Basic medical/therapeutic area and medical terminology knowledge
Basic knowledge of local health systems
Working knowledge of GCP and applicable SOPs
Ability to work in a matrix environment
Ability to manage risk and perform risk escalation appropriately
Occasional drives to site locations and potential occasional travel

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial Database SystemsDocument ReviewStudy Metrics AnalysisVendor TrackingTranslation Quality ControlRisk ManagementSite Selection DocumentationFeasibility Study ConductSOP KnowledgeMedical Terminology

Soft Skills

Organizational SkillsAttention to DetailEffective CommunicationInterpersonal SkillsPresentation Skills

Tools & Technologies

ETMFCTMSActivate

Industry Keywords

Clinical TrialsRegulatory DocumentsInvestigator Site FileHealth SystemsClinical Training Program