Regulatory Affairs Specialist I - Lifelancer

Its More Than a Career, Its 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 Regulatory Affairs Specialist your primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. You will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance and prepare for audit activities while meeting strict deadlines.

• You will establish and maintain a document management system for regulatory paper and electronic files

• 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 (SOPs) for format and content

• You will maintain updated physician credentials for network participants and other critical documentation ensuring compliance

• You will modify and/or develop informed consent forms and update and manage protocol and consent form modifications or amendments in compliance with Institutional Review Board (IRB) policy and HIPAA

• You will organize and coordinate IRB documentation for trials

• You will provide initial review and triage of Investigational New Drug (IND) Safety Reports as delegated by the Principal Investigator, and perform subsequent processing of those Safety Notifications that meet the IRB reportable criteria

• You will assist any internal or external audit team with any regulatory related issues

• You will apprise Regulatory Affairs Manager and Network Management, if applicable, of all study and site-specific regulatory issues for guidance

• You will archive study specific regulatory documentation and correspondence

You should have for this position:

• A Bachelor Degree

• Knowledge of scientific and clinical research terminology is essential

• Knowledge of IRB, FDA and GCP guidelines required

• Two years in healthcare, research or other science related field

• Safety experience in clinical research or other healthcare environment

• Direct regulatory affairs experience

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the worlds 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. SCRIs 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. Thats 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.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/4ae2c78ae48763e174719b82be89ac5f