Reg Affairs Specialist
Company: Loma Linda University Health
Location: Loma Linda
Posted on: January 23, 2023
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Job Description:
- Clinical Trial Center - (Full-Time, Day Shift) -
Our mission is to participate in Jesus Christ's ministry, bringing
health, healing, and wholeness to humanity by: Creating a
supportive faculty practice framework that allows Loma Linda
University School of Medicine physicians and surgeons to educate,
conduct research, and deliver quality health care with optimum
efficiency, deploying a motivated and competent workforce trained
in customer service and whole person care principles and providing
safe, seamless and satisfying health care encounters for patients
while upholding the highest standards of fiscal integrity and
clinical ethics. Our core values are compassion, integrity,
humility, excellence, justice, teamwork and wholeness.
The Regulatory Affairs Specialist is responsible for maintenance
and submission of all regulatory documentation. This position
assists with study related analysis and other clinical research
submission requirements, supporting various UHC clinical
departments. Performs other duties as needed.
Bachelor's degree in health care or related field required. Minimum
one year of research related experience required. Experience in
regulatory affairs in a medical setting preferred. Seven years of
experience in research related regulatory work in lieu of degree
required. Certified Clinical Research Coordinator (SoCRA, ACRP)
within one year of eligibility required.. Valid Driver's License
required at time of hire.
Knowledge of HIPAA guidelines; good clinical practice; ICH
guidelines. Able to keyboard 40 wpm. Able to use a computer,
printer, and software programs necessary to the position (e.g.,
Word, Excel, Outlook, PowerPoint). Operate/troubleshoot basic
office equipment required for the position. Able to work calmly and
respond courteously when under pressure; collaborate and accept
direction. Able to think critically; manage multiple assignments
effectively; organize and prioritize workload; work well under
pressure; problem solve; recall information with accuracy; pay
close attention to detail; work independently with minimal
supervision. Able to distinguish colors as necessary; hear
sufficiently for general conversation in person and on the
telephone, and identify and distinguish various sounds associated
with the workplace; see adequately to read computer screens, and
written documents necessary to the position
Additional Information
Compensation
US Dollar (USD)
21.35
US Dollar (USD)
30.18
Keywords: Loma Linda University Health, Fontana , Reg Affairs Specialist, Other , Loma Linda, California
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