Safety Coordinator
McKesson
Country: United States of America
Location: USA, TN, Remote
Time Type: Full time
Posted On: September 28, 2024
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 Safety Coordinator you are responsible for helping to provide daily case processing for initial and follow-up Serious Adverse Event (SAE) and Averse Events of Special Interest (AESI) reports in the Sarah Cannon Drug Development Unit (DDU). You will work closely with the Safety Nurse Coordinator and DDU Data Operations team to complete follow-up SAE reports and resolve SAE queries.
You will review protocol to determine SAE and AESI reporting criteria, completion, and submission of SAE and AESI reports, processing and filing SAEs, and SAE metric reporting.
You will review patient updates to assess qualification for protocol-required SAE reporting and AESI reporting.
You will process incoming initial SAE reports and review with Safety Nurse Coordinator
You will provide copies of completed and reviewed initial SAE report to pharmaceutical partner(s) in the required time-frame as per sponsor and IRB requirements.
You will maintain and archive documentation of SAE case receipt of distribution
You will enter SAE report data for initial and follow-up SAE reports into SAE tracking database
You will report weekly and monthly SAE metrics to designated stakeholders (data team members, manager)
You will collaborate with the DDU Data Operations team to address SAE report queries and escalate to Safety Nurse Coordinator as needed.
You will participate in Site Initiation Visits to gain protocol knowledge for SAE reporting.
For this position, you must have:
High School Diploma (GED)
One year in a healthcare, research, or other science related field or equivalent of education and experience
It is preferred that you have:
Bachelor’s Degree (4 year program)
Experience working in medical record review, safety reporting, or drug interactions in a clinical trial environment
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 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 .
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.