Research Compliance Specialist | Clinical Research
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Facility: Sanford Education Campus Building
Location: Sioux Falls, SD
Address: 1410 W 25th St, Sioux Falls, SD 57105, USA
Job Schedule: Full time
Weekly Hours: 40.00
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. 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 up-to-date 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 multi-site institution and occasional local travel between sites may be required.
Bachelor’s degree is required.
Healthcare Science background is preferred. Two years’ experience is required.
Certification is encouraged.
Sanford Health offers an attractive benefits package for qualifying full-time and part-time employees. Depending on eligibility, a variety of benefits include health insurance, dental insurance, vision insurance, life insurance, a 401(k) retirement plan, work/life balance benefits, sick leave and paid time off. To review your benefit eligibility, visit https://sanfordhealth.jobs/benefits .
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 call 1-877-673-0854 or send an email to email@example.com .
Sanford Health has a Drug Free Workplace Policy. An accepted offer will require a drug screen and pre-employment background screening as a condition of employment.
Job Function: Legal and Compliance
Req Number: R-36082