Develop and maintain source documents and submit case report forms (CRFs) as required for clinical trials.

Recognize and report 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.

Maintain trial regulatory documentation files as directed, including correspondence with sponsor, IRB, departmental support and participants.

Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and other team members.

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.

Participate in continuing education, research and training.

Coordinate study participant visit activities including scheduling procedures and 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 relevant experience. Relevant education may substitute for experience on a year for year basis.

Preferred Qualifications

Education: Bachelor's degree in relevant field.

Work Experience:

• Experience in research and clinical studies in human subjects, including coding experimental stimulus paradigms in E-Prime, Presentation, PsychoPy, or other software.
• Experience in general computing such as working with the UNIX command line (Mac/Linux), and programming in MATLAB, R, Python, or other language.
• Experience with MR imaging data analysis (AFNI, SPM, FSL, or other tools).
• Experience with statistical analysis software (SPSS, SAS, R, or similar).

Skills

• Communication skills
• Organization
• Detail-Oriented
• Time management
• Microsoft Office

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. https://www.kumc.edu/human-resources/benefits.html

Employee Type:
Regular

Time Type:
Part 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

Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Clinical-Research-Assistant---Neurology--PROMUS-Lab---Part-Time-_JR010520-1 or go to https://careers.kumc.edu/ and search for position number JR010520.

Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.

About KU Medical Center:
The University of Kansas Medical Center's mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu.

Benefits:
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html

Equal Employment Opportunity Statement

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">http://policy.ku.edu/IOA/nondiscrimination

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Develop and maintain source documents and submit case report forms (CRFs) as required for clinical trials.

Recognize and report 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.

Maintain trial regulatory documentation files as directed, including correspondence with sponsor, IRB, departmental support and participants.

Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and other team members.

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.

Participate in continuing education, research and training.

Coordinate study participant visit activities including scheduling procedures and 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 relevant experience. Relevant education may substitute for experience on a year for year basis.

Preferred Qualifications

Education: Bachelor's degree in relevant field.

Work Experience:

• Experience in research and clinical studies in human subjects, including coding experimental stimulus paradigms in E-Prime, Presentation, PsychoPy, or other software.
• Experience in general computing such as working with the UNIX command line (Mac/Linux), and programming in MATLAB, R, Python, or other language.
• Experience with MR imaging data analysis (AFNI, SPM, FSL, or other tools).
• Experience with statistical analysis software (SPSS, SAS, R, or similar).

Skills

• Communication skills
• Organization
• Detail-Oriented
• Time management
• Microsoft Office

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. https://www.kumc.edu/human-resources/benefits.html

Employee Type:
Regular

Time Type:
Part 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

Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Clinical-Research-Assistant---Neurology--PROMUS-Lab---Part-Time-_JR010520-1 or go to https://careers.kumc.edu/ and search for position number JR010520.

Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.

About KU Medical Center:
The University of Kansas Medical Center's mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu.

Benefits:
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html

Equal Employment Opportunity Statement

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">http://policy.ku.edu/IOA/nondiscrimination

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