HCA, Hospital Corporation of America Protocol Interpreter in Nashville, Tennessee
Sarah Cannon is the research arm of HCA’s global cancer enterprise. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.
_Summary of Key Responsibilities:_Directs the clinical interpretation of protocols and transfers this interpretation into the detailed schedule of events that must be completed with each patient visit. The schedule of events provides the procedures that must be performed in the clinic and, also serves as the inventory of procedures to be priced in the budget and contracting function of the organization. The Clinical Protocol Interpreter also works with the Protocol Educators to ensure the training design is consistent with the protocol requirements and the procedures that will be performed in the clinic.
_Duties and Responsibilities:_ Duties include but are not limited to: • Serve as scientific and clinical expert in the interpretation of clinical trial protocols. • Work directly with Scientific Director and/or Physicians and/or Program Managers to validate proper interpretation of the protocol. • Prep for the SCRI 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 • 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 • Attend the SCRI Clinical Operations Protocol Review Committee to capture any details presented by the clinical and budget teams • Convert 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. • Provide initial clinical interpretation for each protocol and guide the Clinical Educators to insure consistent interpretation across the organization. • Escalate all appropriate information to budgets, finance, or Clinical Operations management as deemed necessary. • Report necessary metrics on appropriate time frames.
_Knowledge:_ • 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
_Abilities:_ • 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
_Education:_ Bachelor Degree required; Master Degree preferred
_Experience:_ • Oncology knowledge • Three or more years of clinical operations experience • Three or more years of research experience • Experience in a research setting and/or quality department is preferred
_Certification or License:_ RN or BSN preferred Research Certification (ACRP or CCRP) preferred Oncology Certification (OCN) preferred
Job: *Education Training & Professional Development
Title: Protocol Interpreter
Location: Tennessee-Nashville-Sarah Cannon Clinical Operations
Requisition ID: 03058-5402