Site Manager (4138)
On-siteHouston, Texas, United States or Bellaire, Texas, United States
Job Summary
Oversee quality research at assigned investigative sites by ensuring adherence to sponsor protocols, FDA regulations, and ICH/GCP guidelines. Supervise site staff, complete required training including ICH-GCP and IATA certifications, and manage clinical trial operations from first patient visit to study closeout. Ensure visit preparedness for sponsor and CRO visits, maintain accurate data reporting, and drive subject enrollment to meet sponsor goals. Coach employees, enforce site-specific policies, and communicate strategic objectives to the team. Submit administrative paperwork on time and attend investigator meetings as needed. This role supports the clinical research organization's mission to deliver high-quality data while maintaining strict compliance with ALCOA-C standards.
Required Qualifications
- Bachelor's degree preferred
- Advanced degree preferred
- At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization
- Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred
- Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail
- Critical Thinking
- Active Listening
- Reading Comprehension — Understanding written sentences and paragraphs in work-related documents
- Speaking and Writing to communicate effectively as appropriate for the needs of the audience
- Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams
- Strong computer skills in relevant software and related clinical systems are required
- Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs
- Proficient communication and comprehension skills both verbal and written in the English language are required
- Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred
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