Coordinator – Oncology Research Regulatory Affairs & Compliance Position Available In Mecklenburg, North Carolina

•Job Summary•Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including

FDA/OHRP

guidance, GCP and ICH. •Essential Functions•+ Fulfills the job responsibilities of the

Oncology Research Specialist, and:

+ Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information. + Assesses patient eligibility through chart reviews and patient/family interviews. + Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial. + Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers; coordinates documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required. + Presents and obtains patient informed consent. + Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data. + Coordinates and prepares for internal and external audits. + Participates in sponsor study start-up and follow-up meetings as appropriate. + Develops study calendars. + Collaborates on billing and financial activity with Research Finance (budgets and billing compliance). + Coordinates scheduling of patient visits, labs, and diagnostic procedures. + Coordinates drug shipments, storage, and accountability with IDS/Pharmacy. + Assists in the development, improvement and review of Standard Operating Procedures and processes. + Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates. •Physical Requirements•Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials. •Education, Experience and Certifications•Bachelor’s Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master’s Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. Atrium Health is one of the nation’s leading healthcare organizations, connecting patients with on-demand care, world-class specialists and the region’s largest primary care network. A recognized leader in healthcare delivery, quality and innovation, our foundation rests on providing clinically excellent and compassionate care. We’ve been serving our community since 1940, when we opened our doors as Charlotte Memorial Hospital. Since then, our network has grown to include more than 40 hospitals and 900 care locations ranging from doctors’ offices to behavioral health centers to nursing homes.

Our focus:

Delivering the highest quality patient care, supporting medical research and education, and joining with partners outside our walls to keep our community healthy.