Sarah Cannon, the Cancer Institute of HCA Healthcare, offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation provided by oncology-trained nurses, more than 1,000 stem cell transplants performed annually throughout the Sarah Cannon Blood Cancer Network, hundreds of clinical trials, and molecular profiling capabilities. Through its services, Sarah Cannon is providing state-of-the-art cancer care close to home for hundreds of thousands of patients, a number unmatched by any single cancer center.
By bringing together a network of globally-recognized cancer experts, we are collaborating and sharing best practices that address every aspect of the cancer journey, from screening and diagnosis through treatment and survivorship.
Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 260 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.
Summary of Position:
This position will provide assistance and support for the Sarah Cannon Medical Directors who oversee trials conducted by Sarah Cannon Development Innovations. Key responsibilities will include study start up review and education, participation in key study-related meetings, ongoing data review with a specific focus on patient safety and to ensure that the data is coherent, complete, and accurate in such a way so that it is suitable to meet scientific deliverables within Sarah Cannon and potentially for external scientific publications and presentations. The Clinical Scientist will follow standard operating procedures, ICH-GCP, and all applicable regulatory requirements.
Duties and Responsibilities
Duties include but are not limited to: * Serve as an individual on the study core team with clinical, therapeutic and scientific expertise * Facilitate and assist with the scientific review of Sarah Cannon protocols, case report forms, and mock TFLs * Assist with preparation of study specific Medical Monitoring Plan (MMP) and review and provide input to the study specific Safety Monitoring Plan (SMP) * Participate in study kick off, core team, sponsor, and site meetings as requested * Assist Medical Directors with indication or mechanism of action training for study team * Work with study team to develop site training materials * Assist Medical Directors in site training requirements including Site Initiation Visits * Review the integrity of the clinical data as per the MMP or Data Management Plan (DMP) * Utilize J-Review software for review of patient data * Assist the Medical Directors in scientific and safety-driven review of patient data as appropriate and provide medical/scientific leadership to data and safety reviews to ensure consistency * Scientifically review clinical research data including patient demographics, medical history, concomitant medications, laboratory values, adverse events, and disease response verification * Create data summaries for scientific meetings, manuscripts and other data reviews as required * Review and assist in the preparation outlines of scientific manuscripts, abstracts and presentations for professional and scientific meetings Participate in cross functional research team meetings as needed to ensure quality work product in a matrix-driven environment* *
A body of information needed to perform a tasks; May be obtained through education, training or experience * Understanding of regulatory guidelines and GCP is required * Understanding of response evaluation criteria and staging systems for solid and liquid tumors is required * Ability to understand and effectively interface in multiple types of institutions
The proficiency to perform a certain task * Proficient in Microsoft Office software, including Word, PowerPoint and Excel; high computer literacy and ability to learn new software if required * Excellent interpersonal skills, detailed-oriented and meticulous * Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment * Ability to effectively communicate with different types of clinical research and medical professionals
An underlying, enduring trait useful for performing duties * Ability to manage, problem solve, organize, and make decisions * Highly organized, ability to handle multiple priorities efficiently
Bachelor’s Degree (4 year program)
* At least 3 years’ experience in clinical research and/or oncology-focused laboratory-based research, with experience in an academic or community medical center, or in the pharmaceutical, biotechnology, contract research industry or similar research entity preferred. * Demonstrated leadership skills * Prior experience mentoring and/or training less senior team members
* At least 5 years’ experience in clinical research and/or oncology-focused laboratory-based research, with experience in an academic or community medical center, or in the pharmaceutical, biotechnology, contract research industry or similar research entity preferred. * Research certification
If interested in advancing your career with a growing leader in clinical research please apply today!*
Tennessee-Nashville-Sarah Cannon Clinical Operations