Job Description

Job Title: Clinical Research Associate

Company Overview

At Vibrant Wellness, a leading wellness and diagnostic company dedicated to advanced laboratory testing for micronutrients, genetics, hormones, and personalized health solutions, we are committed to advancing clinical research that empowers individuals with actionable insights for optimal well?being. Our clinical studies evaluate innovative marker?supplement interactions and remeasurement of health markers to guide personalized wellness interventions. We seek a high?energy Clinical Research Associate (CRA) to coordinate multiple studies, manage sample sourcing/logistics, and drive efficient execution while collaborating with research sites, labs, and data teams.

Position Summary

The Clinical Research Associate will coordinate multiple clinical studies focused on marker?supplement interactions and health marker remeasurement for wellness optimization. This in?person role involves site management, sample sourcing/processing, regulatory compliance, data coordination, and cross?functional collaboration to ensure timely, high?quality results. The ideal candidate is a proactive, high?energy individual who thrives in a fast?paced environment, excels at keeping projects moving, and has strong organizational skills to manage MTAs, sample tracking, and multi?site logistics. This position supports Vibrant Wellness's mission of innovative health research with real?world impact.

Key Responsibilities

• Study Coordination : Manage 5?10 concurrent clinical studies, including protocol implementation, site initiation, monitoring, and close?out across multiple U.S./international sites.
• Site Management : Select, train, and monitor 10?20 research sites; conduct on?site visits (20?30% travel), ensure GCP compliance, and resolve issues to meet enrollment timelines.
• Sample Sourcing & Logistics : Source biological samples (blood, saliva, urine) from sites, vendors, and collaborators; coordinate collection, shipping, and storage per IATA/GxP standards.
• MTA & Agreement Management : Draft, negotiate, and maintain Material Transfer Agreements (MTAs) and Researcher Consulting Agreements; ensure legal/compliance review and execution.
• Sample Tracking & Information : Maintain centralized databases for sample information (e.g., donor ID, collection date, volume, condition) and results; ensure chain?of?custody documentation.
• Lab Coordination : Partner with internal labs to prioritize sample runs, troubleshoot delays, and ensure timely turnaround .
• Data Management & Analysis : Collect, clean, and transfer sample results to data analysis team; collaborate on statistical analysis (e.g., SAS/R) and biomarker correlations.
• Reporting & Presentations : Prepare interim reports, data summaries, and presentations for research collaborators, PIs, and steering committees; support manuscript submissions.
• Regulatory Compliance : Prepare IRB/ethics submissions, SAE reporting, and DSMB materials; ensure 21 CFR Part 11, HIPAA, and GCP adherence.
• Participant Recruitment : Develop strategies to meet enrollment targets (50?300 participants/study); manage diversity/inclusion and retention efforts.
• Timeline Oversight : Track study milestones and vendor payments; mitigate delays to achieve 95% on?time completion.
• Cross?Functional Collaboration : Work with R&D, labs, biostatisticians, and external collaborators to integrate sample data into study analyses and publications.
• Quality Assurance : Conduct risk assessments, CAPAs, and audits; maintain study master files for regulatory inspections.
• Other Usual Responsibilities : Vendor qualification, safety monitoring, protocol deviations management, and training for new CRAs.

Required Qualifications

• Bachelor's/Master's in Life Sciences, Nursing, or related field; CRA certification (CCRA) preferred.
• 3+ years coordinating multi?site clinical studies in diagnostics, wellness, or nutrition research.
• Proven experience managing MTAs, sample logistics, and lab coordination .
• Strong knowledge of GCP, ICH?GCP, 21 CFR Part 11, HIPAA , and FDA regulations for diagnostics.
• Proficiency in CTMS (e.g., Medidata Rave) , REDCap , and Excel for sample tracking.
• Excellent organizational skills with ability to handle 5+ concurrent studies.

Preferred Skills

• Experience in marker?supplement interaction studies or health marker remeasurement research .
• CCRC/CCRP certification and IATA shipping certification .
• Familiarity with biomarker analysis and multi?omics data integration .
• High?energy, proactive mindset to keep things moving in fast?paced environment.
• Strong communication for site/lab/collaborator interactions.
• 401(k) matching, stock options, and performance bonuses.
• 25+ PTO days and professional development stipend.
• In?person work with access to state?of?the?art labs and research facilities in Santa Clara.

Ideal Candidate Profile

A high?energy, detail?oriented CRA who excels at multi?tasking, problem?solving, and driving study success through proactive coordination. Join Vibrant Wellness to advance personalized wellness research!

Seniority level

Mid?Senior level

Employment type

Full?time

Job function

Research, Analyst, and Information Technology

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