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Company | Sarah Cannon |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Research Services |
Expires | 2023-07-03 |
Posted at | 11 months ago |
It’s More Than a Career, It’s a Mission.
- You will review all proposed amendments to understand the impact to the clinical trial. You will adjust the schedule of events to capture any adjustments specified by trial amendments.
- You will work directly with Scientific Director and/or Physicians and/or Program Managers to validate proper interpretation of the protocol.
- You will attend the Sarah Cannon Clinical Operations Protocol Review Committee to capture any details presented by the clinical and budget teams
- You will serve as scientific and clinical expert in the interpretation of clinical trial protocols.
- You will provide initial clinical interpretation for each protocol and guide the Clinical Educators to insure consistent interpretation across the organization.
- You will prepare for the Sarah Cannon Clinical Operations Protocol Review Committee by evaluating and assessing presenting protocols in advance to determine complexity, identify risks associated with a trial and operational and implementation challenges
- You will update the Clinical Trial Management System with the original or updated schedule of events to ensure timely notification to impacted parties.
- You will create and update the protocol specific Clinical Operation worksheet with pertinent study information to use as a study lead tool for SCRI Clinical Operations and applicable sites
- You will convert the protocol into a schedule of events which should be completed with each patient visit during the life of the study.
- At least three years of research experience
- Registered Nurse (RN) or BSN preferred
- Knowledge and understanding of the principles, processes, and ethical considerations in clinical trials involving human subjects.
- Extensive oncology knowledge base of all major cancer types including disease-related symptom management, standard treatment options, and treatment-related side effect management
- The ability to work at a fast pace while maintaining attention to detail
- A Bachelor Degree, preferably a Master Degree
- Knowledge of federal and state regulations and ICH guidelines pertaining to the conduct of clinical trials involving human subjects for Investigator and Sponsor requirements.
- Oncology knowledge
- Oncology Certification (OCN) preferred
- At least three years of clinical operations experience
- Research Certification (ACRP or CCRP) preferred
- Experience working in a research setting and/or quality department is preferred
- A general working knowledge of the guidelines, standards and operating requirements of Institutional Review Board
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