Senior Specialist, Clinical Research
$105,500–$168,800 year
On-site · Irvine, California, United States
Job Summary
Senior Specialist, Clinical Research responsible for planning, executing, and overseeing clinical studies for medical devices. Lead design, development, and review of study protocols and essential documents; manage day-to-day trial operations (site selection, initiation, monitoring, close-out); ensure compliance with GCP, FDA, ISO, and SOPs; collaborate with R&D, Regulatory Affairs, Quality Assurance, and Marketing; monitor progress, mitigate risks, review data, prepare regulatory submissions, and oversee CROs. Serve as SME for clinical research processes and guide junior team members. Travel up to 20%. Requires BS in a scientific/biomedical field; MS preferred; 5+ years in clinical research; CTMS/EDC proficiency; strong communication skills.
Required Qualifications
- Bachelor's degree in a scientific, biomedical engineering, or health-related field
- Minimum of 5 years of experience in clinical research, preferably within the medical device industry
- Knowledge of Good Clinical Practice (GCP), FDA regulations, and ISO 14155 or other international standards
- Experience in managing clinical trials from initiation to close-out
- Proficiency with CTMS and electronic data capture (EDC) systems
- Excellent written and verbal communication skills; ability to interact with stakeholders
- Ability to travel domestically and internationally as needed (up to 20%)
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