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University of Kansas Medical Center · 3 days ago
Regulatory Coordinator
Kansas City metropolitan area, KS
Full-time
Hybrid
Entry, Mid Level
$26.13/hr - $39.20/hr
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Responsibilities
Prepare and submit all regulatory documents, including study documents to the Institutional Review Board.
Collaborate with team members to ensure accuracy and completion of regulatory documents.
Maintain trial master file and/or regulatory binder.
Assist study monitors during routine visits or audits if needed.
Update protocol-specific systems with accurate protocol and study information.
Address regulatory and safety concerns by working closely with investigators, study personnel, and sponsors.
Perform other relevant duties as assigned by the supervisor.
Qualification
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Required
Bachelor’s degree in relevant field of study.
Experience with regulations governing clinical research (CFR, GCP, HIPAA).
Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
Experience using the Microsoft Office Suite.
Experience with medical terminology and concepts.
Preferred
Research certification preferred such as: Certified Clinical Research Coordinator (CCRC) or certification eligible; Certified Clinical Research Professional (CCRP) or certification eligible; Collaborative Institutional Training Initiative (CITI) training certification or other research certification eligible.
Experience working independently.
Excellent communication, interpersonal, analytical and problem-solving skills.
Multitasking skills.
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Health Expense Accounts
Employer-paid Life Insurance
Long-term Disability Insurance
Various Additional Voluntary Insurance Plans
Paid Time Off (Vacation and Sick)
Ten Paid Holidays
One Paid Discretionary Day after six months
Paid Time Off for Bereavement, Jury Duty, Military Service, and Parental Leave
Retirement Program with Generous Employer Contribution
Additional Voluntary Retirement Programs (457 or 403b)
Company
University of Kansas Medical Center
The University of Kansas Medical Center strives to educate exceptional health care professionals.
Founded in 1906
1,001-5,000 employees
H1B Sponsorship
University of Kansas Medical Center has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (28)
2022 (30)
2021 (48)
2020 (24)
Funding
Current Stage
Late StageTotal Funding
$27MKey Investors
National Center for Advancing Translational Sciences(NCATS)
2022-09-21Grant· $27M
Leadership Team
Sean Roberts
Chief Technology Officer
Chris Harper
Chief Information Officer
Recent News
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