Clinical Research Associate (Site Director)
$160,000–$210,000 year
RemoteUnited States
Job Summary
Manage overall clinical site management, including site identification, feasibility, pre-study evaluation, start-up, initiation, patient recruitment, monitoring, close-out, and inspection readiness for Phase I-IV studies. Serve as the primary point of contact for sites through all study phases, ensuring compliance with ICH-GCP guidelines, SOPs, and local regulations while protecting patient rights and data integrity. Lead site performance, resolve quality issues, and facilitate audits, IRB/EC submissions, and budget negotiations. Execute remote data review, query resolution, and recruitment retention planning. Requires 3+ years of site monitoring experience, 50-65% travel, and a Bachelor's degree in Life Sciences. Candidates based in the Midwest are preferred.
Required Qualifications
- Bachelor's Degree in a Life Science discipline
- Minimum 3 years of direct site monitoring experience
- Detailed understanding of all aspects of clinical site monitoring
- Understanding of overall drug development
- Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations
- Excellent critical thinking skills
- Ability to understand complex patient histories, medical terminology and treatment landscapes
- Ability to interpret study level metrics data
- Ability to proactively identify and mitigate risks through study lifecycle
- Detail-oriented, organized and committed to quality and consistency
- Results-driven and capable of managing competing high-priority assignments
- Proven track record of achieving deliverables within specified timelines
- Excellent team-interaction skills
- Ability to work successfully in team settings
- Ability to work in a dynamic environment
- High degree of flexibility
- Ability to contribute to the culture of process improvement
- Focus on streamlining processes
- Adding value to the company business and needs
- Excellent written and verbal communication skills
- Must be willing and able to travel up to 50-65%
- Candidates based in Midwest region are preferred, but proximity to a major airport and flexibility for multi-day travel are essential
- Must be able to travel frequently (50–65%)
Desired Qualifications
- Bachelor's Degree in Nursing or RN
- Experience and proven proficiency in CTMS and eTMF systems
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