Clinical Research Coordinator - Surgery Urology
University of Kansas Medical Center•Kansas City, MO
•Onsite
About The Position
The Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
Requirements
- Four (4) years of experience in health sciences, nursing, biology, or related field. Relevant education may be substituted for experience on a year for year basis.
- Two (2) years of clinical research experience.
- Experience with clinical research regulations (FDA, GCP, IRB, HIPAA).
Nice To Haves
- Four (4) years of clinical research experience.
- Experience in department or division specific.
- Experience with REDCap, Epic, or similar data management systems.
Responsibilities
- Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
- 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 clinical staff 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.
- Track 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 Project Manager, 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 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.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health expense accounts with generous employer contributions
- Employer-paid life insurance
- Long-term disability insurance
- Various additional voluntary insurance plans
- Paid time off, including vacation and sick
- Ten paid holidays
- One paid discretionary day after six months of employment
- Paid time off for bereavement
- Paid time off for jury duty
- Paid time off for military service
- Paid parental leave after 12 months of employment
- Retirement program with a generous employer contribution
- Additional voluntary retirement programs (457 or 403b)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
