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You will be updated with latest job alerts via email$ 65000 - 99000
1 Vacancy
Required Qualifications:
Education/Certifications:
Associates degree or an equivalent combination of relevant postsecondary education and work experience that equals at least 2 years
At least one of the following certifications:
Certified Clinical Research Coordinator(CCRC)
Certified Clinical Research Professional(CCRP)
Work Experience:
4 years related work experience
Advanced understanding of regulations governing clinical research (CFR GCP HIPAA).
Experience with study budgets contracts and grant applications.
Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research as evidenced by application materials
Preferred Qualifications
Education:
Masters degree in relevant field.
Skill:
Business and financial acumen to assist in developing study budgets contracts and grant applications.
Ability to fully contribute to multidisciplinary teams including physicians and administrative staff.
Ability to effectively manage competing priorities and deadlines.
Job Duties
Under the direction of the principal investigator recruit educate potential patients for and evaluate potential patient eligibility for clinical trials.
Assist clinical staff with maintaining 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.
Assist clinical staff with study procedures as outlined in the protocol and within state and KUMC scope of practice.
As requested facilitate monitoring visits reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager as required.
Prepare and maintain clinical trial contract documents and study budget reports.
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 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.
Attend continuing education research and training seminars as requested by manager.
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.
Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
Reviews and assists with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population budget and specific needs for the study.
Assist Principal Investigators with internal and external funding application submissions
Assure that all professional nursing care provided is conducted in accordance with all KUMC and other regulatory requirements and is in accordance with the scope of practice for the nursing license held
Other relevant duties as requested by the supervisor.
Required Documents
Resume
Cover letter showing how you meet the required and preferred qualifications.
3 professional references
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. Employerpaid life insurance longterm 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. Type: Regular 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 Midpoint MaximumTime Type:
Full timeRate Type:
SalaryPay Range:
$65000.00 $99000.00
Required Experience:
Senior IC
Full-Time