The work location for this position is full remote with occasional time onsite, however the selected candidate must live and work from one of the New England states (ME, NH, VT, MA, RI, CT) The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, national protocol and investigator registrations, clinical trials education, and committee management. The Associate Director of Research Systems and Operations (ADRSO) supervises all Clinical Research Systems Specialists and reports to the Director of ODQ. The Clinical Research Systems Specialist (CRSS) ensures the accuracy of research data in the OnCore CTMS, performs centralized subject randomization for DF/HCC-initiated clinical trials, conducts feasibility reviews of new protocols, and facilitates activation of protocols and submissions in iRIS. Clinical Research Systems Specialists may be required to rotate coverage for after-hours patient care critical requests, as deemed necessary by the ADRSO. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Subject Registration Perform randomization and registration of clinical trial subjects for DF/HCC investigator-sponsored, randomized trials. Provide after-hours coverage for patient care critical registration issues (rotating schedule). Routinely review de-centralized subject registrations for data entry quality control. Ensure registrations are entered in accordance with DF/HCC policies, and that registrations successfully interface to downstream clinical systems, including OnCore, Epic, COE, BOE, and InForm EDC. OnCore CTMS Quality Control Review data in the OnCore CTMS for accuracy, completeness, and compliance with DF/HCC policies. Monitor OnCore QC reports and facilitate timely resolution of error flags. Facilitate the activation of new protocols, amendments and other submissions in iRIS. Perform a feasibility review of submissions to verify key operational components and compliance with DF/HCC policies (e.g., registration plan, data management plan, data safety monitoring plan, randomization schema, etc.) Facilitate activation of submissions by verifying readiness for activation, updating OnCore status information and formatting and posting final study documents. Create and post study-specific eligibility checklists when necessary. Track expiration of protocols and automatic closures in OnCore and update posted documents on OncPro, as necessary. Assist in the training of new Clinical Research Systems Specialists on regulatory compliance issues, computer systems, policies and procedures. Participate in other ODQ special projects and activities as requested by the ADRSO Bachelor of Science or Bachelor of Arts with scientific specialty or other relevant major Familiarity with regulatory requirements and best practices related to the conduct of human subject research (e.g., FDA regulations, ICH GCP) is preferred. 2+ years of prior experience working in a medical or scientific research setting. Ability to communicate clearly and effectively with written and verbal English. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law. EEOC Poster