- Four (4) years of related work experience.
- Experience with regulations governing clinical research (CFR, GCP, HIPPA).
- Experience with statues and guidelines relevant to regulatory affairs.
- Customer service experience.
- Master's Degree (Finance, Business Administration, Management).
- Master Excel Certified.
- CRA, CCRP, CCRC.
- Four (4) years' experience in large clinical unit within academia or research administration.
- Experience using Workday/Velos.
- Organizational skills.
- Excellent written and verbal communication skills.
- Analytical/problem solving skills.
- Assisting PI with investigator-initiated studies across multiple agencies, including protocol development, reviewing consent forms, budget planning and following.
Interface with study sponsors and study team members during study start-up and maintenance regarding regulatory documents, other regulatory issues or contract modifications. Provide updates as required, escalate as appropriate. - Perform start-up activities including submission of study documents to the Institutional Review Board, maintaining timeline goals and escalating delays appropriately, collaborating with team members to ensure regulatory documents are completed and accurate. Completion and maintenance of study file documents according to requirements of ICH GCP E6 and Regulatory Agencies' guidance and standards.
- Provide assistance to study monitors during routine monitor visits or audits
- Update protocol and study information into the Clinical Trial Management System (Velos) for team collaboration.
- Support the management or perform analytical and financial activities associated with cost of studies, forecasting, planning, and managing clinical portfolios.
- Review clinical trial protocol amendments and revise amendments with principal investigators, study teams, and clinical trial contract associates. Prepare clinical trial amendment documents and memos as requested. Submit amendments to the IRB approval.
- Maintain clinical trial amendment information in appropriate database.
- Prepare study approvals for the study team once IRB approval is received. Prepare continuing review documents and work with the study team to receive
- Other duties as assigned.
- Resume/CV
- Cover Letter
-
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Regulatory Coordinator - Kansas City, United States - University of Kansas Medical Center
Description
Description
:Required Qualifications
Education : Bachelor's Degree. Professional, related experience may be substituted for the education requirement on a year-for-year basis.
Work Experience :
Preferred Qualifications
Education/Certification :
Work Experience :
Skills :
Job Duties Outlined:
Required Documents:
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 nine 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:
RegularTime Type:
Full timeRate Type:
SalaryCompensation 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:
$54, $80,000.00Minimum
$54,000.00Midpoint
$67,000.00Maximum
$80,000.00
