- Manage site management, monitoring, and close-out of assigned clinical trial investigator sites
- Ensure patient safety and quality study execution according to applicable laws, GCP, and sponsor standards
- Manage investigator site relationships and operational aspects from site activation through database lock
- Serve as primary contact for assigned investigator sites and collaborate with Site Care Partners and study teams
- Facilitate information flow among study team members, vendors, and investigator sites
- Train and coach site personnel on protocols and compliance
- Support site activation, patient recruitment, enrollment, and investigator meetings
- Conduct onsite and remote/electronic site initiation, routine monitoring, and close-out activities
- Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
- Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, study progress, and metrics
- Identify and resolve site issues and develop corrective and preventive actions
- Resolve data queries and prepare and conduct site close-out activities
- Oversee investigational product receipt, handling, accounting, storage, and destruction
- Support database release and perform unblinded monitoring when appropriate
- Maintain product, protocol, and therapy-area knowledge and support patient safety and clinical guidance
- Drive Quality Event remediation and audit observation CAPA activities when applicable
Requirements
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations
- Minimum 2 years of relevant experience in clinical research site monitoring
- Fluent in English and the native language(s) of the country of work
- Ability to travel 60–80%
- Valid driver’s license and passport required
- Bachelor’s degree in life sciences, or professional degree in life sciences such as nursing, pharmacy, or medical background, or equivalent
- Ability to conduct onsite and remote/electronic monitoring
- Knowledge of protocol, therapy area, patient safety, eligibility, and clinical guidance
- Location specified as United States/Arizona/Remote United States
Core Competencies
Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations, with a strong focus on patient safety and quality study execution. Proficient in managing investigator site relationships and conducting both onsite and remote monitoring activities.
Highest-signal resume keywords
- Clinical Trial Methodologies
- ICH/GCP Compliance
- Site Monitoring Experience
- Patient Safety Management
- Fluent in English
ATS Optimization Keywords
Hard Skills
- Clinical Trial Management
- Site Activation
- Patient Recruitment
- Protocol Compliance
- Data Query Resolution
- Adverse Event Monitoring
- TMF Documentation
- CAPA Activities
- Remote Monitoring
- Investigational Product Handling
Soft Skills
- Collaboration
- Training and Coaching
- Problem Solving
- Communication
Certifications & Qualifications
- Bachelor’s Degree in Life Sciences
- Valid Driver’s License
- Passport
Industry Keywords
- Clinical Research
- FDA Regulations
- GCP Standards
- Site Management
- Investigator Meetings
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Clinical Research Associate II/Sr. Clinical Research Associate Arbeitgeber: Jobtailor
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