Clinical Operations Manager
On-siteAustin, Texas, United States
Job Summary
Oversee daily operations of clinical research staff and studies, coordinating multiple projects with competing priorities and deadlines. Monitor adherence to protocols and study timelines while acting as the primary liaison with sponsors, CROs, and vendors. Prepare for and facilitate study monitor visits, ensuring compliance with SOPs, FDA regulations, and other regulatory references. Supervise creation of study-related documents, case report forms, and adverse event documentation. Manage subject screening, recruitment, appointment scheduling, and visit implementation, including phlebotomy and specimen processing. Directly supervise Clinical Research Coordinators and Research Assistants, handling training, performance appraisals, and problem resolution. Requires a Bachelor's degree and three to five years of experience in a Clinical Research Coordinator role, with Good Clinical Practice and IATA certifications. Occasional domestic and international travel is required.
Required Qualifications
- High school diploma or GED
- Bachelor's degree
- Three to five years of experience in a Clinical Research Coordinator role
- Good Clinical Practice training certification
- IATA training certification
- Valid driver's license and insurance
- Strong oral and written communication abilities
- Excellent organizational skills and attention to detail
- Professional interpersonal skills with a positive demeanor
- Adaptability to changing priorities
- Medical knowledge including terminology
- Thorough understanding of regulations, regulatory guidance, and SOPs
- Proficiency with Microsoft Office, web browsers, and electronic case report form systems
- Occasional domestic and international travel
- Ability to maintain upright/stationary position for 6-10 hours daily
- Frequent mobility required
- Occasional squatting, kneeling, or bending
- Light to moderate lifting (20-50 lbs)
Desired Qualifications
- Previous experience managing clinical research coordinators
- For CNS sites, experience conducting rating scales such as MMSE
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