Posted:
8/18/2024, 5:00:00 PM
Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior
Field(s):
Medical, Clinical & Veterinary
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Medicine - Allergy Immun RheumJob Duties Outlined
Under the guidance of the principal investigator, recruit, educate, and assess potential patients for eligibility in clinical trials.
Manage the scheduling of study subject visits, and study monitoring visits, including booking the visit room, confirming the visit, and coordinating and booking any other relevant appointments with other departments that are required for the visit.
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.
Conduct 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.
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.
Work Environment: This role is fully on site.
Required Qualifications
Education: Associate’s degree or an equivalent combination of relevant post-secondary education and work experience that equals at least two years.
Work Experience:
Two years’ experience in health care, academic, and/or research experience.
Solid understanding of regulations governing clinical research (CFR, GCP, HIPAA) as evidenced by application materials.
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research as evidenced by application materials.
Experience with study budgets, contracts, and grant applications.
Preferred Qualifications
Work Experience:
Experience working with multidisciplinary teams including physicians, and administrative staff.
> 1 year of phlebotomy and sample collection/processing experience.
Experience with recruiting and consenting patients in clinical trials.
IATA Certification or willingness to obtain or renew (experience in shipping and handling hazardous materials.
Experience with performing Pulmonary function testing/spirometry.
Skills
Excellent communication, writing, organizational, and presentation skills.
Excellent organizational/multitasking skills.
Excellent presentation and communication skills
Excellent interpersonal skills and ability to effectively interact with multidisciplinary teams including, physicians, hospital, and administrative staff.
Strong work ethic, detail oriented and ability to prioritize and meet deadlines.
Required Documents
Resume
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
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
$58,000.00Midpoint
$72,000.00Maximum
$86,000.00Website: https://kumc.edu/
Headquarter Location: Kansas City, Missouri, United States
Year Founded: 1905