Clinical Research Assistant - ONC Radiation Oncology

Department:

SOM KC Radiation Oncology

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Radiation Oncology

Position Title:

Clinical Research Assistant - ONC Radiation Oncology

Job Family Group:

Professional Staff

Job Description Summary:

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.

The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. Radiation Oncology department is recognized nationally as a leader in cancer research, care and education. We are an integral part of The University of Kansas Cancer Center, the only National Cancer Institute (NCI)-comprehensive designated Cancer Center in the state of Kansas and the Kansas City metro area. Our world-class physician faculty provide compassionate and state-of-the-art care for KU Cancer Center patients. We are leading the way with research and clinical trials that aim to improve cancer treatments, increase cure rates, decrease treatment-related side effects and improve quality of life.

Job Description:

Key Roles and 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. 

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 this 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:

• 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

Education: Bachelor's degree in healthcare or a related field

Work Experience:

• 1 year of experience with research or within the healthcare field

• Experience with electronic medical records and working knowledge of medical terminology.

Skills:

• Organizational skills

• Communication skills

Required Documents:

• Resume/CV

• Cover Letter

Comprehensive Benefits Package:

Coverage begins on day one