Clinical Research Assistant

University of Kansas Medical Center; Kansas City (KS); On-site; USD 30,000 - 45,000; Full time

Benefits offered by this job

Health, dental, and vision insurance (

Paid time off and holidays

Retirement program

Job summary

University of Kansas Medical Center in Kansas City, KS is seeking an entry‑level Clinical Research Assistant to support cancer center trials. You will collect information from patients and families, prepare CRFs, and provide data and documentation to physicians, sponsors, and CROs.

The role emphasizes ethics, confidentiality, and adherence to GCP/FDA guidelines. The position involves coordinating visit activities, maintaining study documents, and assisting in monitoring and QA activities to

Qualifications

• Two (2) years of work experience in healthcare or research setting.
• Relevant education may substitute on a year for year basis.
• Bachelor’s degree in health sciences, biology, nursing, or related field preferred.
• Strong communication, initiative, organization and attention to detail are expected.

Responsibilities

• 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.

Skills

Communication skills

Self-initiative

Organization

Detail-Oriented

Computer skills

Education

Bachelor’s degree in relevant field

Job description

Department: SOM KC Cancer Center Clinical Trials ----- Clinical Program Management Position Title: Clinical Research Assistant - 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. The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

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 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: 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

Comprehensive Benefits Package

• 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.

Employee Type: Regular 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 requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.

Pay Range: $22.88 - $33.17 Minimum $22.88 Midpoint $28.03 Maximum $33.17

The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care. The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information. http://policy.ku.edu/IOA/nondiscrimination https://kumc-publicpoliciesandprocedures.policystat.com/policy/8446235/latest/ Under Kansas state law, certain KUMC positions are subject to disability preference. For positions subject to this requirement, KUMC will offer an interview to a person who has applied for an open position who is qualified, with or without reasonable accommodation, to meet the performance standards of the position and who has presented acceptable proof of disability. If the position you apply for is subject to the disability preference requirement, you will be asked to provide information in support of your request for disability preference when you complete the application for employment. https://civilrights.ku.edu/annual-security-and-fire-safety-report https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf https://www.laborposters.org/federal/1606-federal-pay-transparency-poster.htm