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Protocol Interpreter

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Nashville, TN, United States

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Description

SHIFT: No Weekends

SCHEDULE: Full-time

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.

Benefits:
We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.

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.

Qualifications

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


We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Notice

Our Company’s recruiters are here to help unlock the next possibility within your career and we take your candidate experience very seriously. During the recruitment process, no recruiter or employee will request financial or personal information (Social Security Number, credit card or bank information, etc.) from you via email. The recruiters will not email you from a public webmail client like Gmail or Yahoo Mail. If you feel suspicious of a job posting or job-related email, let us know by clicking here.

For questions about your job application or this site please contact HCAhrAnswers at 1-844-422-5627 option 1.

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Sarah Cannon Network
Facility: Sarah Cannon Network
Job ID: 03058-6491
Category: Education Training and Professional Development
Contract: Full-time
Shift: No Weekends
Job Class: Regular

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