Site Manager (4139)
$100,000–$120,000 year
On-siteJersey City, New Jersey, United States
Job Summary
Oversee quality research at assigned investigative sites by ensuring adherence to sponsor protocols, FDA regulations, and ICH/GCP guidelines to deliver high-quality data. Manage site staff performance, coordinate training on protocols, EDC systems, and study manuals, and enforce site-specific policies and productivity standards. Ensure visit preparedness for sponsor and CRO teams, maintain strict ALCOA-C data standards, and drive enrollment goals while coaching employees and submitting administrative paperwork. Communicate strategic objectives to the site team and facilitate patient consent discussions. This role supports clinical trial management from first patient visit to study closeout within a clinical research organization.
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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