Clinical Trial Manager
Clinical ResearchClinical ResearchFull TimeRemoteTeam 201-500Since 2010H1B No SponsorCompany SiteLinkedIn
Location
Illinois + 2 moreAll locations: Illinois, Minnesota, Texas
Posted
170 days ago
Salary
$95K - $125K / year
Bachelor Degree5 yrs expEnglish
Job Description
• Oversight and management of all clinical operational activities at the trial and site level
• Interact with Heartflow Clinical Research staff and collaborate with onsite and field staff, clinical research coordinators, principal investigators, and vendors
• Develop clinical trial timelines, enrollment projections, instructional materials, and project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participate in and lead process improvement activities, including SOP development
• Conduct study start-up activities including development of protocols, informed consent forms, source document worksheets, and training presentations
• Review site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintain effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary
Job Requirements
- Ability to work in a smaller team environment with a willing, all hands on deck attitude
- Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
- High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
- Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
- Excellent written and oral English communication skills required
- Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint
- Bachelor’s degree in science or health related field
- Demonstrated 5 years minimum relevant experience required
- Experience in cardiovascular medical device clinical research a plus
- Travel required: up to 25%
Benefits
- cash bonus
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