Good Samaritan Society
Director, Institutional Review Board (IRB)
Good Samaritan Society, Sioux Falls, South Dakota, United States, 57102
Job Overview
Facilities: 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 Job Summary
The Director of the Institutional Review Board (IRB) has several duties that include the leadership and responsibility for the oversight, administration, and coordination of policies and procedures related to the protection of the rights and welfare of human subjects in research and to ensure compliance with all federal, state, and local regulations and applicable institutional policies as well as Accreditation of Human Research Protection Programs (AAHRPP). Direct both the administrative and educational components of the IRB. Direct the human subject research protection program. Delegate tasks and have strategic plans for the flow of work. Establish, evaluate, and oversee the administrative operations, policies and procedures of the (3) Institutional Review Boards. Coordinate problems, issues, and decisions with IRB leadership, staff, and board members, research investigators, Sanford Clinical Research team, Sanford Compliance Office, and Risk Management Office. Advise Sanford Institutional Official (IO) regarding the needs of IRB operations, upcoming regulatory requirements, appropriateness of reliance on external IRBs, policy changes, and IRB membership. Provide ultimate oversight of IRB office personnel and human resources issues, budget and the development of broad educational programs. Determine business necessity and oversee Research IT during implementation and upgrades to IRB software in order to maintain IRB operations. Manage the interaction process between IRB and government auditors. Responsible for assessment of external IRB functions and IRB workflow decision making during potential merger opportunities. Responsible for leading initial and annual submission process for (AAHRPP) accreditation. Qualifications
Bachelor’s degree required. Master’s degree preferred. Minimum of five years of related experience and a thorough knowledge of institutional Review Board (IRB) practices and relevant federal regulations and guidance is required. Experience as an IRB member is highly desired as well as clinical experience. Training in a medical or allied health field is desired. Administrative management (financial management and personnel management training and experience) is also desired. Other combination of relevant education and experience will be considered. Knowledge and understanding with a variety of regulations from the Food and Drug Administration (FDA), Office for Human Research Protections (OSHA), Environmental Protection Agency (EPA), Health Insurance Portability and Accountability Act (HIPPA), and Defender of Justice (DOJ). Certified IRB Professional (CIP) certification is required. Opportunity to earn certificate once in role. 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-0234102 Job Function:
Research Featured:
No
#J-18808-Ljbffr
Facilities: 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 Job Summary
The Director of the Institutional Review Board (IRB) has several duties that include the leadership and responsibility for the oversight, administration, and coordination of policies and procedures related to the protection of the rights and welfare of human subjects in research and to ensure compliance with all federal, state, and local regulations and applicable institutional policies as well as Accreditation of Human Research Protection Programs (AAHRPP). Direct both the administrative and educational components of the IRB. Direct the human subject research protection program. Delegate tasks and have strategic plans for the flow of work. Establish, evaluate, and oversee the administrative operations, policies and procedures of the (3) Institutional Review Boards. Coordinate problems, issues, and decisions with IRB leadership, staff, and board members, research investigators, Sanford Clinical Research team, Sanford Compliance Office, and Risk Management Office. Advise Sanford Institutional Official (IO) regarding the needs of IRB operations, upcoming regulatory requirements, appropriateness of reliance on external IRBs, policy changes, and IRB membership. Provide ultimate oversight of IRB office personnel and human resources issues, budget and the development of broad educational programs. Determine business necessity and oversee Research IT during implementation and upgrades to IRB software in order to maintain IRB operations. Manage the interaction process between IRB and government auditors. Responsible for assessment of external IRB functions and IRB workflow decision making during potential merger opportunities. Responsible for leading initial and annual submission process for (AAHRPP) accreditation. Qualifications
Bachelor’s degree required. Master’s degree preferred. Minimum of five years of related experience and a thorough knowledge of institutional Review Board (IRB) practices and relevant federal regulations and guidance is required. Experience as an IRB member is highly desired as well as clinical experience. Training in a medical or allied health field is desired. Administrative management (financial management and personnel management training and experience) is also desired. Other combination of relevant education and experience will be considered. Knowledge and understanding with a variety of regulations from the Food and Drug Administration (FDA), Office for Human Research Protections (OSHA), Environmental Protection Agency (EPA), Health Insurance Portability and Accountability Act (HIPPA), and Defender of Justice (DOJ). Certified IRB Professional (CIP) certification is required. Opportunity to earn certificate once in role. 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-0234102 Job Function:
Research Featured:
No
#J-18808-Ljbffr