Clinical Research Assistant - ONC Radiation Oncology

The Clinical Research Assistant assists in entry level clinical research activities. Under general supervision, the Clinical Research Assistant works with multidisciplinary teams including patients/study participants, families, physicians, administrative staff, and sponsor and CRO representatives to assist in coordination of all aspects of clinical research. This encompasses study recruitment, pre-screening for eligibility, data entry, maintenance of regulatory files, study visit scheduling, and collection data within scope of role. Responsibilities Assist in recruitment, evaluation, and education of patients regarding clinical trials following established procedures and protocols. Develop and maintain source documents and submit case report forms (CRFs) as required for clinical trials. Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors. Perform study procedures, as outlined in the protocol and within state and institutional scope of practice. Assist with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy. Ensure adequate study supplies are being maintained. May track and document study visits in the Clinical Trials Management System, study expenditures and submit reimbursement requests for study equipment, supplies and study participants. Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and other team members, as required. Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR. Work with the Research Administration, Department Administrators and Human Research Protection Program and have a working knowledge of KUMC policies and procedures. Coordinate study participant visit activities including scheduling procedures, communicating with participants. Participate in continuing education, research, and training. Qualifications Work Experience 4 years of experience with research or within the healthcare field. Education may substitute for experience on a year for year basis. Data management experience with Microsoft Excel, REDCap, CRIS, Access, or other electronic data capture systems. Preferred Qualifications Bachelor's degree in healthcare or a related field. 1 year of experience with research or within the healthcare field. Experience with electronic medical records and working knowledge of medical terminology. Organizational skills. Communication skills. Benefits Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. Employment Details Employee Type: Regular Time Type: Full-time Rate Type: Hourly Compensation Pay Range: $22.88 - $33.17 Minimum: $22.88 Midpoint: $28.03 Maximum: $33.17 #J-18808-Ljbffr