Coordinator II Clinical Research Bariatric GI
Overview
Day shift coordinator leading clinical trial execution at HonorHealth Research Institute. Manages data support and collaboration with research staff to ensure FDA compliance and GCP adherence. Oversees recruitment screening and informed consent processes. Serves as liaison with sponsors and handles study startup closeout tasks. This role drives operational efficiency and supports continuous improvement initiatives.
What You'll Do19
- 1Manage clinical data management for complex protocols ensuring FDA and ICH guidelines compliance
- 2Coordinate recruitment screening and informed consent procedures
- 3Collect verify organize and record clinical information accurately
- 4Assist with subject follow-up and document clinical study progress
- 5Submit data forms pathology and radiology materials per protocol requirements
- 6Conduct protocol administration quality control monitoring
- 7Participate in site initiation interim monitoring and closeout visits
- 8Handle sample handling shipping and labeling according to protocol specifications
- 9Facilitate setup and closure of clinical protocols
- 10Develop tools for team performance monitoring and process optimization
- 11Communicate performance metrics and positive trends to management
- 12Train staff on new systems and coordinate weekly workload tracking
- 13Assist in creating departmental operating procedures
- 14Represent coordination team in meetings and support business development proposals
- 15Perform monthly quality checks verifying documentation and deadline compliance
- 16Identify regulatory deviations and support IRB reporting processes
- 17Collaborate with leadership to address data management challenges
- 18Maintain communication regarding safety and regulatory concerns
- 19Precept and train staff on data management procedures
Requirements10
- 15+ years clinical research coordination experience
- 24 years health science education
- 32 years clinical or clinical research experience
- 4Pharmaceutical sponsored investigator initiated trials preferred
- 5Knowledge of ICH GCP and FDA regulations
- 6Strong project management skills
- 7Proficiency in Microsoft Office Suite and EDC systems
- 8Basic Life Support certification required
- 9Clinical Research Certification preferred
- 10IATA Certification preferred
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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