Clinical Research Consultant

About The Job

Company Overview

Inquisite is an AI-powered platform designed to accelerate and de-risk clinical development. Our mission is to transform life sciences R&D so that treatments get into the hands of patients faster, cheaper and with less risk. We are a spin-out from Duke University.

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Position Summary

We are seeking a Fractional Clinical Research Expert with experience in clinical trial design and protocol development to serve as a part-time consultant and scientific advisor for the Inquisite platform development. This role is crucial in ensuring our platform meets the real-world needs of clinical researchers and regulatory requirements while incorporating industry best practices.

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Key Responsibilities

Strategic Guidance & Product Direction

• Provide expert input on clinical trial design methodologies and industry standards
• Review and guide product roadmap decisions to ensure alignment with clinical research needs
• Advise on regulatory compliance requirements and industry best practices

Platform Development Support

• Evaluate platform features and functionalities from a clinical perspective
• Provide feedback on user experience and workflow optimization for clinical researchers
• Suggest enhancements to improve protocol development efficiency and accuracy

Protocol Development Expertise

• Review and provide input on protocol template designs and standardization features
• Advise on statistical design considerations and sample size calculations
• Guide development of risk assessment and mitigation strategy tools

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Required Qualifications

Education & Credentials

• Advanced degree (PhD, MD, PharmD, or equivalent) in relevant field preferred

Professional Experience

• Minimum 5+ years of hands-on experience in clinical trial design and protocol development
• Proven track record of designing Phase I-IV clinical trials across multiple therapeutic areas
• Experience with regulatory submissions (FDA, EMA, or other global regulatory bodies)
• Direct experience writing and reviewing clinical trial protocols

Technical Expertise

• Deep understanding of ICH-GCP guidelines and regulatory requirements
• Proficiency in statistical design principles for clinical trials
• Knowledge of risk-based monitoring and quality-by-design principles
• Familiarity with clinical trial technologies

Preferred Qualifications

• Experience at pharmaceutical/biotech companies, CROs, or academic medical centers
• Background in multiple therapeutic areas (oncology, cardiology, neurology, etc.)
• Experience with adaptive trial designs and innovative methodologies
• Experience with clinical trial software platforms or digital health technologies

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Work Arrangement & Compensation

Work Structure

• Part-time consultant position (estimated ~5 hours per week, flexible based on project needs)
• Fully remote work arrangement
• Flexible scheduling to accommodate existing commitments

Compensation

• Competitive hourly rate commensurate with experience
• Payment structure: hourly basis with monthly invoicing

What We Offer

• Opportunity to shape the future of clinical trial design technology
• Collaboration with a dynamic, innovative team
• Direct impact on improving clinical research efficiency and patient outcomes