Clinical Project Associate

Clinical Project AssociateIt'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 MissionPeople 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 Clinical Project Associate, you are responsible for ensuring the Trial Master File (TMF) is set-up and maintained in "audit ready" condition; and conduct critical documentation collection and review throughout the lifecycle of the study, in accordance with Good Clinical Practices, ICH Guidelines, Federal Regulations and Development Innovations SOPs. You will maintain clinical trial management systems and tracking tools, actively participating in cross-functional teams to ensure delivery of project deliverables.This position is remote based in the US; relocation assistance and visa sponsorship are not available.Duties include and are not limited to:Set-up, document collection/upload of files to the TMF/eTMFPerform initial quality review of documents prior to upload/filing in the TMF/eTMFPartner with document specialist to maintain the Trial Master File (TMF) in "audit ready" condition from study start to completionAssist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trialPerform critical document distribution to and collection from the investigative sites throughout the lifecycle of the clinical trial. Proactively liaise with Clinical Research Associate and investigative site to resolve outstanding regulatory issuesReview study documents to ensure they are current, complete and accurateOther duties as assignedQualifications needed:Minimum High School Diploma or GEDAt least 1 year of clinical research experience required; at least 3 years of clinical research experience preferred.Oncology clinical research experience preferredAbout Sarah Cannon Research InstituteSarah 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.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.