Associate Research Compliance Specialist

at  Sanford Health

SANFORD HEALTH IS ONE OF THE LARGEST AND FASTEST-GROWING NOT-FOR-PROFIT HEALTH SYSTEMS IN THE UNITED STATES. WE’RE PROUD TO OFFER MANY DEVELOPMENT AND ADVANCEMENT OPPORTUNITIES TO OUR NEARLY 50,000 MEMBERS OF THE SANFORD FAMILY WHO ARE DEDICATED TO THE WORK OF HEALTH AND HEALING ACROSS OUR BROAD FOOTPRINT.

Facility: 700 Building Clinic
Location: Fargo, ND
Address: 700 1st Ave S, Fargo, ND 58103, USA
Shift: 8 Hours - Day Shifts
Job Schedule: Full time
Weekly Hours: 40.00
Salary Range: $21.50 - $34.50

JOB 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. 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.

QUALIFICATIONS

Bachelor’s degree is required.
Healthcare Science background is preferred.
Certification is encouraged.