Institutional Review Board (IRB) Specialist

Facility: Sanford Center Building
Location: Sioux Falls, SD
Address: 2301 East 60th St N, Sioux Falls, SD 57104, USA
Shift: 8 Hours - Day Shifts
Job Schedule: Full time
Weekly Hours: 40.00
Salary Range: 21.50 - 34.50

Department Details

This is an exempt position, eligible for remote officing after sufficiently trained. The work of the IRB is never boring but always rewarding.

Job Summary

The Institutional Review Board (IRB) Specialist ensures submitted research is reviewed efficiently and consistently with federal regulation and Sanford Policy. Maintains accurate records of Institutional Revenue Board (IRB) determinations, conveys IRB determinations in minutes and Investigator communications. Serves as the IRB interface and demonstrates professionalism when interacting with research investigators, sponsors, regulatory agencies, the Institutional Official, IRB members, IRB chairs. Demonstrates the ability to utilize software applications for maximum efficiency as well as the ability to identify, analyze and resolve compliance issues. Maintains strict confidentiality of sensitive information. Knowledge and application of Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulations and guidance documents.

Exhibits an ability to evolve skills to changes in process and contribute to process evaluation. Self-directed with a high level of accountability and works with minimal supervision. Functions as a resource for employees and clients. Works in stressful conditions and must manage stress well. Excellent time management and organizational skills. Excellent communication skills relating in person or on telephone as well as strong interpersonal skills.

Carries out all responsibilities and tasks as detailed in Sanford Institutional Review Board Policy. Serves in role of IRB member to conduct independent (free from immediate direction or supervision) protocol review and has authority to act on behalf of the IRB: to approve research, conduct protocol pre-review, require changes for IRB approval.

Coordinates research protocol submission process with Clinical Research staff, investigators; and provides education to fellow IRB members, Clinical Research staff, and investigators. Exercises independent judgment with regard to federal guidance and documents rationale for deviating from standard practice or established policies or procedures when in the best interest of research participants.

The work performed on behalf of the IRB is conducted in an effort to protect human research participants, and maintain Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation standards to protect the credibility of the institution.

Qualifications

Bachelor’s degree required or minimum six years of work experience.

Collaborative Institutional Training Initiative (CITI) training is required as well as on the job (OTJ) training. OTJ training includes two years of Institutional Review Board (IRB) specific training. Knowledge and application of Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations and guidance documents.

Certified IRB Professional (CIP) certification is preferred.

Benefits

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, and a generous time off package to maintain a healthy home-work balance. For more information about Total Rewards, visit https://sanfordcareers.com/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 talent@sanfordhealth.org .

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.

Req Number: R-0224409
Job Function: Research
Featured: No