Senior Clinical Research Associate – Onco

Worldwide Clinical Trials

. Lead site qualification, initiation, monitoring, and close-out activities in accordance with protocols, GCP, SOPs, and applicable regulations .

Posted 10/31/2026full-timeRemote • TaiwanSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical research monitoring and site management, with a thorough knowledge of ICH-GCP, FDA, and EU regulations. Proficient in building relationships with investigative sites and ensuring compliance throughout the clinical trial lifecycle.

Highest-signal resume keywords

Clinical Research Associate ExperienceICH-GCP KnowledgeEDC Systems ProficiencyRegulatory ComplianceTherapeutic Area Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research MonitoringSite ManagementData SubmissionSource Documentation ReviewSafety ReportingInformed Consent ProcessesInvestigational Product AccountabilityOperational Process EvaluationClinical Monitoring PlansTraining Program Development

Soft Skills

Excellent CommunicationOrganizational SkillsTime ManagementProblem-Solving SkillsInterpersonal Skills

Tools & Technologies

EDC SystemsIxRS PlatformsMicrosoft Office Applications

Certifications & Qualifications

MDPharmacy DegreeMSPHPharmDPhD

Industry Keywords

GCPSOPsClinical Trial LifecycleRegulatory DocumentationInspection ReadinessStudy MilestonesBid Defense ActivitiesFull-Service Monitoring

About the role

Key responsibilities & impact

Lead site qualification, initiation, monitoring, and close-out activities in accordance with protocols, GCP, SOPs, and applicable regulations
Build relationships with investigative sites and provide ongoing support for study quality, compliance, and timely data submission
Review source documentation, study data, safety reporting, and informed consent processes
Coordinate and maintain regulatory and ethics documentation and ensure inspection readiness
Collaborate with project teams to track study milestones, resolve operational challenges, and support study delivery
Mentor and guide less experienced CRAs and site personnel
Contribute to clinical monitoring plans, study tools, training programs, investigator meetings, and bid defense activities
Evaluate investigational product accountability, site compliance, and operational processes
Document findings through clear and accurate reports
Partner with sites, sponsors, and global study teams throughout the clinical trial lifecycle

Requirements

What you’ll need

MD, Pharmacy degree (MSPH, PharmD, PhD, or equivalent) plus a minimum of 3 years of Clinical Research Associate experience; OR a four-year degree in a medical, biological, physical, health, pharmacy, or related science field plus 5 years of CRA experience; OR a two-year college curriculum/equivalent training (nursing or life sciences preferred) plus 7 years of CRA experience
Extensive experience in clinical research monitoring and site management across the clinical trial lifecycle
Thorough knowledge of ICH-GCP, FDA and/or EU regulations, local regulatory requirements, and clinical research processes
Strong understanding of at least two to three therapeutic areas with the ability to function as a Lead CRA
Experience using EDC systems, IxRS platforms, and Microsoft Office applications
Excellent communication, organizational, time management, problem-solving, and interpersonal skills
Proficiency in English and fluency in the local language(s) of the countries under responsibility, both written and spoken
Full-service monitoring experience preferred
Must reside in Taiwan
Ability to travel to investigative sites approximately 8-10 days per month
Willingness to travel regionally and occasionally to other locations as needed

Benefits

Comp & perks

Home-based work arrangement
Opportunity to learn and grow
Collaborative and inclusive work environment
Mentoring and professional development opportunities
Global team collaboration
Meaningful work supporting life-changing therapies