Description
Required Qualifications
Education :
Associate degree plus two years related work experience OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
Work Experience :
Experience with regulations governing clinical research (CFR, GCP, HIPAA).
Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
Experience with study budgets, contracts, and grant applications
Skills :
Solid understanding of regulations governing clinical research (CFR, GCP, HIPAA). Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
Knowledgeable of study budgets, contracts, and grant applications
Preferred Qualifications
Work Experience :
Experience working with multidisciplinary teams including physicians, and administrative staff.
Skills :
Excellent communication, writing, organizational, and presentation skills.
Excellent organizational / multitasking skills.
This position is onsite on KUMC Campus. Flexible work arrangements are at the discretion of the hiring manager with the expectation this role will be primarily on campus daily.
Job Duties Outlined
Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
Management of biorepository.
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 the 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 the manager.
Other relevant duties as requested by the supervisor.
A complete application includes :
Resume
Cover letter showing how you meet the required and preferred qualifications.
3 professional references
This is a rolling Evergreen posting that continually accepts applications for numerous open positions within Internal Medicine.
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
Regular
Time Type : Full time
Full time
Rate Type : Salary
Salary
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 :
$58,000.00 - $86,000.00
Minimum
$58,000.00
Midpoint
$72,000.00
Maximum
$86,000.00
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