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 highl