Sr Regulatory Affairs Specialist - Remote US

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.

Our Senior Regulatory Affairs Specialist is responsible and accountable for coordinating the activities of physicians and the clinical team with respect to creating and maintaining required essential regulatory documents. This position ensures compliance with regulatory requirements. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, improve regulatory processes, and handle multiple tasks while meeting strict deadlines. The Senior Regulatory Affairs Specialist (SRAS) will have mastered the responsibilities of the Regulatory Affairs Specialist and require little to no supervision. The SRAS will carry an expanded study workload.

This is a US-based remote position; relocation assistance and visa sponsorship are not available.

Duties include and are not limited to

• You maintain our FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content.

• You will ensure that essential regulatory documents are created and maintained for all assigned studies. You will ensure that these regulatory documents are completed in a timely way to meet department and sponsor timelines.

• You maintain updated physician credentials.

• You modify and/or develop informed consent forms and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA.

• Other duties as assigned.

Qualifications needed for success:

• Minimum High School Diploma/GED obtained - Bachelor’s Degree or equivalent combination of education and experience may be substituted

• Minimum 3 years’ work experience in the Regulatory Affairs Specialist role

• Strong knowledge of scientific and clinical research terminology

• Knowledge of IRB, FDA, and GCP guidelines

• SOCRA Certification and/or ACRP Certification highly preferred

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 850 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 in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ 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.

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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.