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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Design, plan, coordinate, and conduct clinical research studies across assigned sites.
- Act as the primary contact and clinical trial expert for assigned study site personnel, delivering technical assistance and coordinating necessary training.
- Perform comprehensive site assessments and qualification visits to drive informed site selection decisions.
- Collaborate cross-functionally to ensure investigational sites properly obtain and maintain institutional approvals and meet all regulatory compliance needs before trial initiation.
- Author and review key study site documents, including Study Monitoring Plans, informed consent forms, and case report forms.
- Execute all data generation, data validation, and comprehensive site visits across all study phases, from start-up through to close-out.
- Work dynamically within local, global, and virtual study teams, collaborating with R&D, Field Service, Study Management, and Biometrics to deliver top-tier solutions.
Requirements
What you’ll need- A Bachelor's degree in a scientific discipline or a related field (or an equivalent combination of education and experience).
- Hands-on experience in a clinical laboratory or clinical lab study coordination is highly valued.
- Typically brings professional experience, with solid conceptual and practical knowledge of clinical operations or diagnostic product development.
- Good knowledge of, and strict adherence to, clinical trial and laboratory standards, including ICH-GCP guidelines, FDA Regulations, and IVDR.
- Proven ability to partner across diverse regions, cultures, and time zones to cultivate an environment of belonging, inclusion, and diversity.
- Exceptional verbal and written communication skills in English, allowing you to explain complex data clearly in straightforward situations.
Benefits
Comp & perks- Health insurance
- Flexible working arrangements
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchsite assessmentsdata generationdata validationstudy monitoringclinical trial coordinationregulatory complianceinformed consentcase report formsclinical operations
Soft Skills
communication skillscollaborationcross-functional teamworkcultural awarenessinclusiondiversityproblem-solvingtechnical assistancetraining coordinationenvironment cultivation