Clinical Research Coordinator managing the conduct of clinical trials at Emory University. Handling administrative activities and overseeing research project requirements and compliance.
About the role
- Clinical Study Manager overseeing observational trials for Tempus. Responsible for executing trials in compliance with regulations and managing project deliverables.
Responsibilities
- Responsible for executing Tempus’s observational trials in compliance with quality standards (ICH/GCP, Global Regulations, and Tempus policies and procedures)
- Act as primary point of contact for clients.
- Anticipate client needs and proactively resolve issues as necessary
- Lead cross-functional teams and third parties/vendors to ensure effective teamwork and communication
- Manage project deliverables including timeline, quality, scope, and cost
- Maintain study management system(s)
- Develop and maintain project plans
- Primary contact for assigned sites and build positive relationships with investigators and site staff
- Complete monitoring visits and/or oversee Clinical Research Associates, as applicable
- Manage participant recruitment, sample reconciliation, data entry to safe-guard project endpoints
- Responsible for the completeness and quality of the Trial Master File
- Provide temporary coverage/back-up for additional observational studies as required
- May involve overnight travel
Requirements
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology)
- Minimum of five+ (5) years relevant clinical research experience in a combination of research site, life sciences company or CRO
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Demonstrated ability to be self-directed.
- Working knowledge of project finance.
- Familiar with concepts commonly incorporated non-therapeutic studies: risk-based monitoring, quality of life and patient-reported outcomes, health outcomes etc.
- Excellent communication, planning and organizational skills.
Benefits
- incentive compensation
- restricted stock units
- medical and other benefits
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