Research Coordinator

Job Description The Clinical Research Coordinator works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details, and participating in the informed consent process. The role involves accurate and timely source documentation, data collection, documentation, entry, and reporting, including responding to sponsor queries. Essential Functions Independent study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details to the patients, and participating in the informed consent process. Scheduling of patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug. Maintains accurate source documents related to all research procedures. Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries. Schedules and participates in monitoring and auditing activities. Compiles and reports on each study including protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings. Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. May assist with patient research billing and reconciliation. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local IRB. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May coordinate training and education of other personnel. May participate in centralized activities such as auditing and SOP development. Plans and coordinates strategies for increasing patient enrollment and improving clinical research efficiency. Identifies quality and performance improvement opportunities and collaborates with staff to develop action plans. Identifies new research opportunities and presents them to investigators. Participates in required training and education programs. Key Competencies Strong customer service background, preferably in a healthcare setting. Excellent written and verbal communication skills. Knowledge of computer/telephone support, preferably in the healthcare industry. Ability to resolve customer issues calmly and professionally with diplomacy and tact. Education and Experience BA/BS Degree – Preferred. ACRP/SoCRA (or equivalent) certification preferred. Minimum of 1 year of clinical research coordination experience, required. Previous Oncology/Hematology experience preferred. Additional Requirements Great customer service skills. Knowledge of medical terminology, specifically in Oncology/Hematology. Ability to travel to satellite clinics when necessary. Must be willing and able to lift up to 25 pounds. Pay Transparency From $70,304 per year to $75,000 (depending on experience, certification, education, skills, location, etc.) #J-18808-Ljbffr Astera Cancer Care