Safety Coordinator Jobs

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 a Safety Coordinator your primary responsibilities include submission to appropriate review boards and file maintenance of Investigational New Drug (IND) Safety Report and Investigator Brochures. You are other responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or investigator-initiated trials as appropriate. You will work closely with the regulatory affairs management, and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.

• You will maintain Strategic Site credential files and ensure that are accurately up to date
• You will provide administrative support to the Regulatory Affairs Specialist as necessary
• You will organize and coordinate IRB documentation for trials
• You will assist any internal or external audit team with any regulatory related issues
• You will run queries for monthly Institutional Review Board (IRB) submission
• You will attend regulatory staff meetings as appropriate
• You will establish and maintain a document management system for regulatory paper and electronic files and archive study specific regulatory documentation and correspondence
• You will manage the electronic filing of IND Safety Reports and assist in processing Safety Notifications per the Sarah Cannon policy and related Working Practice Guidelines (WPG) under the supervision of the Regulatory Affairs Specialist and Lead Regulatory Affairs Specialist
• You will maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks. You will ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
• You will generate IRB submissions of Investigator Brochures including event summaries for cover letter, compilation of individual submissions, preparation of multiple copies for submission and filing
• You will interact with on-site monitors and respond to queries from pharmaceutical company and study monitors regarding Investigator Brochure status and submissions
• You will oversee the process of obtaining physician signatures as required
• You will work with Network Management team, study managers and regulatory personnel to achieve goals for quality assurance and compliance

You should have for this position:

• Knowledge of scientific and clinical research terminology
• A High School Diploma, preferably an Associate’s Degree
• Ability to work with within deadlines
• Strong interpersonal, communication, and organizational skills
• Knowledge of IRB, FDA and GCP guidelines
• MS Office products including Outlook, Word, and Excel
• Safety experience in clinical research or other health care environment preferred
• At least two years in healthcare, research or other science related field or equivalent of education and experience preferred
• At least one year of database experience

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the world’s leading oncology research organizations conducting community-based clinical trials. In 2022, SCRI formed a joint venture with former US Oncology Research to enhance clinical trial access and availability across the country. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 600 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. The combined research network brings together physicians who are actively accruing patients to clinical trials at more than 250 locations in 26 states across the US. 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.