Clinical Research Assistant (Temporary) - Cancer Center

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13687904 Clinical Research Assistant (Temporary) - Cancer Center Department: SOM KC Cancer Center Clinical Trials ----- Clinical Research - Temps Position Title: Clinical Research Assistant (Temporary) - Cancer Center Job Family Group: Professional Staff Job Description Summary: The Clinical Research Assistant assists in entry level clinical research activities including collecting information from patients/study participants and families. This position provides physicians, administrative staff, sponsors and CRO representatives with requested information and support. This role is ideal for someone taking a gap year to gain clinical research experience before applying to medical school. The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 58 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. Job Description: Job Duties Outlined - Under the direction of the principal investigator, may 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. - Ensure activities are conducted in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations. - Perform job responsibilities in a safe and secure manner. - Develop, maintain and expand job-specific knowledge and skills to keep pace with industry changes and support the university's commitment to excellence and innovation. - May participate in relevant committees, task force, or other similar activities. - Maintain confidentiality of medical center, employee, and patient information. Handle sensitive data with discretion and in accordance with KUMC policies and legal requirements. - Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors. - May perform study procedures, as outlined in the protocol and within state and institutional scope of practice. - 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. - Maintain trial regulatory documentation files as directed, including correspondence with sponsor, IRB, departmental support and participants. - May 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. - May 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 closely with the Research Administration, Department Administrators and Human Research Protection Program and have a working knowledge of KUMC policies and procedures. - Participate in continuing education, research and training. - May coordinate study participant visit activities including scheduling procedures, communicating with participants. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for thi job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice. Required Qualifications: Work Experience: Two (2) years of work experience in healthcare or research setting. Relevant education may substitute on a year for year basis. Preferred Qualifications: Education: Bachelor's degree in relevant field like health sciences, biology, nursing, or a related field. Skills - Communication skills. - Self-initiative. - Organization. - Detail-Oriented. - Computer skills. Required Documents - Resume/CV - Cover Letter Employee Type: Temporary (Fixed Term) Time Type: Full time Rate Type: Hourly Compensation Statement: The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requir