Job Location: Nashville, TN
Overview
Directs the interpretation of protocols, budget documents, and medicare coverage analysis into a structure within the clinical trial management system. Ensures the structure provides the procedures that must be performed in the clinic, and serves as the inventory of procedures to be priced in the budget and contracting function of the organization. Works with the Budget Analyst to ensure the structure design is consistent with the protocol and budget requirements along with the procedures that will be performed in the clinic. Responsible for structure set-up in the clinical trial management system involving corrections and updates. Serves as the system expert to the clinical trial management system.
Responsibilities
- Serve as the system expert of the system build in the Clinical Trial Management System.
- Works directly with Protocol Interpreters to validate proper interpretation of the protocol.
- Converts the protocol into a schedule of events which should be completed with each patient visit during the life of the study.
- Review all proposed amendments to understand the impact to the clinical trial.
- Adjust the schedule of events to capture any adjustments specified by trial amendments.
- Update the Clinical Trial Management System with the original or updated schedule of events to ensure timely notification to impacted parties.
- Review to ensure consistency between the final clinical trial agreement, medicare coverage analysis, and protocol within the Clinical Trial Management System.
- Escalate all appropriate information to budgets, finance, or Research Operations management as deemed necessary.
- Be a resource to internal groups for any structure related questions regarding the build within the Clinical Trial Management System.
- Report necessary metrics on appropriate timeframes.
- All other duties as assigned.
Qualifications
Mandatory:
• Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement”
• During your employment with Sarah Cannon you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
Competencies Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience
• Must have extensive oncology knowledge base of all major cancer types including disease related symptom management, standard treatment options, and treatment-related side effect management • Must have knowledge of federal and state regulations and ICH guidelines pertaining to the conduct of clinical trials involving human subjects for Investigator and Sponsor requirements.
• Must have knowledge and understanding of the principles, processes, and ethical considerations in clinical trials involving human subjects.
• Must have a general working knowledge of the guidelines, standards and operating requirements of Institutional Review Boards
Skills: The proficiency to perform a certain task
• None specified Abilities: An underlying, enduring trait useful for performing duties
• Foster effective working relationships within a team environment
• Work at a fast pace while maintaining attention to detail
• Communicate and work effectively with a diverse team of professionals
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