Research Protocol Coordinator

Sarah Cannon Research Institute

About The Position

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Research Protocol Coordinator you are responsible for assisting with the coordination and support of initiatives and projects within the Research Protocol Operations (RPO) department. This position is based in the US; relocation assistance and visa sponsorship are not available. You will monitor, coordinate and assist process consistency and communications across the Research Protocol Operations department as required. You will manage tracking of RPO department activities in Clinical Trial Management System (CTMS) to include Research Operations Form (ROF) complete, protocol training creation, IRB approval received, coverage analysis creation, receipt of pharmacy manuals, amendment tracking in EMR, amendment processing by education team. You will obtain from sponsor & manage tracking of RPO department activities in eReg platforms, SharePoint Online trackers and SmartSheets to include: SIV dates, request of training slides from sponsor, receipt of training slides. You will assist with communication to sites (ex. Latest News in CTMS). You will upload documents in eReg platforms and CTMS to include clinical summaries, SIV slides, pharmacy manuals, ROF. You will assist with the editing of Standard Operating Procedures (SOPs) and/or Work Instructions (WIs) within RPO department. You should have for this position: Extensive oncology knowledge base of all major cancer types including disease- related symptom management, standard treatment options, and treatment-related side effect management Knowledge of federal and state regulations and ICH guidelines pertaining to the conduct of clinical trials involving human subjects for Investigator and Sponsor requirements. Knowledge and understanding of the principles, processes, and ethical considerations in clinical trials involving human subjects. A general working knowledge of the guidelines, standards, and operating requirements of Institutional Review Boards Experience working in a Clinical Trial Management System and MS Office About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. 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. Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. About McKesson We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. By providing your personal information here, you are acknowledging our privacy statement. (English) http://www.mckesson.com/about-mckesson/privacy-notice-careers-EN/ For information on how we use cookies and other tracking technologies on our website, see our Cookie Notice. http://www.mckesson.com/about-mckesson/cookie-notice/

Requirements

Extensive oncology knowledge base of all major cancer types including disease- related symptom management, standard treatment options, and treatment-related side effect management
Knowledge of federal and state regulations and ICH guidelines pertaining to the conduct of clinical trials involving human subjects for Investigator and Sponsor requirements.
Knowledge and understanding of the principles, processes, and ethical considerations in clinical trials involving human subjects.
A general working knowledge of the guidelines, standards, and operating requirements of Institutional Review Boards
Experience working in a Clinical Trial Management System and MS Office
An Associate’s Degree is required

Nice To Haves

A Bachelor Degree is preferred

Responsibilities

Assist with the coordination and support of initiatives and projects within the Research Protocol Operations (RPO) department.
Monitor, coordinate and assist process consistency and communications across the Research Protocol Operations department as required.
Manage tracking of RPO department activities in Clinical Trial Management System (CTMS) to include Research Operations Form (ROF) complete, protocol training creation, IRB approval received, coverage analysis creation, receipt of pharmacy manuals, amendment tracking in EMR, amendment processing by education team.
Obtain from sponsor & manage tracking of RPO department activities in eReg platforms, SharePoint Online trackers and SmartSheets to include: SIV dates, request of training slides from sponsor, receipt of training slides.
Assist with communication to sites (ex. Latest News in CTMS).
Upload documents in eReg platforms and CTMS to include clinical summaries, SIV slides, pharmacy manuals, ROF.
Assist with the editing of Standard Operating Procedures (SOPs) and/or Work Instructions (WIs) within RPO department.

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