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Clinical Trials Data ManagementJob Duties Outlined
Responsible for the overall knowledge of protocols assigned.
Maintain screening/enrollment logs for each assigned protocol.
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.
Assist with onboarding, mentoring and training junior staff.
Research and resolve any data discrepancies; coordinate final database closure activities and participate in customer audits and improvement initiatives.
Assist with identification and reporting of adverse events/serious adverse events in accordance with ICH/CFR/GCP and specific protocol.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Work closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
Attend continuing education, research and training seminars as requested by manager.
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
Certification: Research certification such as: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) or other related research certification.
Work Experience:
8 years related work experience. Relevant education may substitute for experience on a year for year basis.
Experience with clinical data entry and medical terminology.
Preferred Qualifications
Education: Bachelor's degree
Work Experience:
Oncology experience.
Experience with database software.
Skills
Computer skills.
Communication.
Interpersonal skills.
Organization.
Attention to detail.
Multi-tasking.
Time management.
Required Documents
Resume/CV
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
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.
Minimum
$28.18Midpoint
$35.23Maximum
$42.27