Associate Research Compliance Specialist
Associate Research Compliance Specialist
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Job Description
Sanford Health is one of the largest and fastestgrowing notforprofit health systems in the United States. Were proud to offer many development and advancement opportunities to our nearly 50000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.
Work Shift:
8 Hours Day Shifts (United States of America)Scheduled Weekly Hours:
40Salary Range: $21.50 $34.50Union Position:
NoDepartment Details
Summary
Ensure compliance with the federal and state laws regulations and rules governing healthcare clinical research trials. This includes the rules and regulations concerning Conditions of Participation Code of Federal Regulations Good Clinical Practice and other regulations that govern clinical research trial/studies.Job Description
Reviews and prepares clinical trial documentation for submission of new clinical trials annual reviews amendments addendums and updates to the Institutional Review Board (IRB). Maintains accurate records and data base for volume of clinical trials in preparation for sponsor cooperative group or Food and Drug Administration (FDA) audits and/or inspections. Responsible for organizing and maintaining uptodate clinical trial information including study protocols and informed consent forms for accurate presentation to physicians and study staff to ensure patient safety. Directly communicates with sponsors study staff and IRB Coordinators as it relates to study specific document modifications and IRB requested revisions. Possesses healthcare knowledge or background in clinical research and/or medical terminology. Possesses excellent interactive kills as well as written and verbal communication skills. Ability to demonstrate appropriate conflict resolution in stressful situations. Ability to communicate assertively and collaboratively with all staff. Works with ancillary departments to ensure completion. Adds and removes team members. Possesses excellent organizational skills with great attention to detail. Demonstrates a high level of integrity ethical conduct and trustworthiness. Skillful at managing conflict. Understands and applies a systems approach to problem solving and process improvement involving staff. Competent in computer skills (i.e. Access Excel and Word). Sanford Research is a multisite institution and occasional local travel between sites may be required.Qualifications
Bachelors degree is required.Healthcare Science background is preferred.
Certification is encouraged.
Sanford is an EEO/AA Employer M/F/Disability/Vet.
If you are an individual with a disability and would like to request an accommodation for help with your online application please callor send an email to
Required Experience:
IC
Employment Type
Full-Time
