Duke University
Duke University School of Medicine is the youngest of the nation's top medical schools, established in 1930 and ranked sixth among medical schools it is an inclusive community of outstanding learners, investigators, clinicians, and staff. Interdisciplinary collaboration is embraced and great ideas accelerate the translation of fundamental scientific discoveries to improve human health locally and around the globe. The School is home to more than 2,500 faculty physicians and researchers, more than 1,300 students, and over 6,000 staff. It is part of Duke Health, which also includes the Duke University School of Nursing, the Duke University Health System and the Private Diagnostic Clinic (PDC).
Play a key role in supporting ethical, compliant clinical research at Duke. Be You. This position serves as the primary point of review and guidance within the IRB office. Responsibilities include preliminary reviews of study‑related documents such as renewals, amendments, waiver requests, Notifications of Review Preparatory to Research, and general study correspondence. The role is assigned to specific therapeutic areas within clinical research units (CRUs) that conduct complex or greater than minimal risk interventional trials. The incumbent will interact daily with research personnel in their assigned areas, providing answers and assistance concerning IRB policy and procedures. Additionally, the role offers guidance to all DUHS research personnel on IRB submissions, including electronic IRB submissions.
The candidate will be expected to:
Have demonstrated knowledge of federal regulations and institutional practices;
Answer complex questions from researchers and reviewers;
Assist with educational presentations;
Mentor, train, and onboard new staff;
Provide input and guidance to the development of office practices and updates to the electronic application system;
Have experience working within an IRB;
Be proficient with the electronic application system;
Work with complex CRU portfolios.
Work Arrangement – Hybrid Anticipated Pay Range Duke University provides an annual base salary range for this position from USD $61,535.00 to USD $95,880.00.ਟ The salary is determined by factors such as scope and responsibilities of the position, candidate’s work experience, education/training, and key skills; alongside internal peer equity and market considerations.
Your total compensation extends beyond the base salary. Duke offers comprehensive medical and dental care programs, generous retirement benefits, and a wide array of family‑friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/
MINIMUM QUALIFICATIONS Education/Training
- A bachelor’s degree is required. The role focuses on communication, analytical and organizational skills combined with a general business background.
Experience
- Minimum of two (2) years in an administrative or regulatory environment allowing interpretation and application of regulations. Experience in a human research protections program in the social and behavioral sciences is preferred.
A related master’s degree may offset required years of experience on a 1:1 basis; for example, a two‑year master’s degree can replace two predetermined years of experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.
Essential tasks/responsibilities
Preliminary review of study‑related documents received in the IRB office, including new studies, continuing reviews, amendments, and safety events.
Review and, where necessary, edit consent forms, protocol summaries, and requests for Waiver or Alteration of Consent and HIPAA Authorization to ensure consistency with federal regulations and Duke policy concerning human subjects research.
Determine if amendments, new studies, and renewals qualify for expedited review according to federal regulations.
Coordinate the sending of modification requests, review replies, and issuance of approval letters to research personnel.
Collaborate with one other Board Specialist to build and distribute monthly IRB meeting agendas.
Confirm attendance, arrange lunches (when in‑person meetings occur), maintain quorum counts, and provide administrative assistance to meeting members.
Record minutes of the convened IRB meeting.
Engage more extensively with researchers to answer questions regarding federal regulations and IRB submissions.
Assist Primary Reviewers prior to monthly meetings by answering regulatory or policy questions and providing required documentation.
Participate in educational presentations customized for individual therapeutic areas.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. They are not exhaustive.
Choose Duke. If you enjoy working collaboratively with research teams and serving as a trusted resource, we invite you to apply. Join Duke’s IRB team and help supportekra ethical, high‑quality clinical research through partnership, guidance, and service.
Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy‑related conditions), sexual orientation or military status.čky
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. The collective success depends on the robust exchange of ideas—an exchange that is best when the diversity of perspectives, backgrounds, and experiences flourishes. All members have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
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Play a key role in supporting ethical, compliant clinical research at Duke. Be You. This position serves as the primary point of review and guidance within the IRB office. Responsibilities include preliminary reviews of study‑related documents such as renewals, amendments, waiver requests, Notifications of Review Preparatory to Research, and general study correspondence. The role is assigned to specific therapeutic areas within clinical research units (CRUs) that conduct complex or greater than minimal risk interventional trials. The incumbent will interact daily with research personnel in their assigned areas, providing answers and assistance concerning IRB policy and procedures. Additionally, the role offers guidance to all DUHS research personnel on IRB submissions, including electronic IRB submissions.
The candidate will be expected to:
Have demonstrated knowledge of federal regulations and institutional practices;
Answer complex questions from researchers and reviewers;
Assist with educational presentations;
Mentor, train, and onboard new staff;
Provide input and guidance to the development of office practices and updates to the electronic application system;
Have experience working within an IRB;
Be proficient with the electronic application system;
Work with complex CRU portfolios.
Work Arrangement – Hybrid Anticipated Pay Range Duke University provides an annual base salary range for this position from USD $61,535.00 to USD $95,880.00.ਟ The salary is determined by factors such as scope and responsibilities of the position, candidate’s work experience, education/training, and key skills; alongside internal peer equity and market considerations.
Your total compensation extends beyond the base salary. Duke offers comprehensive medical and dental care programs, generous retirement benefits, and a wide array of family‑friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/
MINIMUM QUALIFICATIONS Education/Training
- A bachelor’s degree is required. The role focuses on communication, analytical and organizational skills combined with a general business background.
Experience
- Minimum of two (2) years in an administrative or regulatory environment allowing interpretation and application of regulations. Experience in a human research protections program in the social and behavioral sciences is preferred.
A related master’s degree may offset required years of experience on a 1:1 basis; for example, a two‑year master’s degree can replace two predetermined years of experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.
Essential tasks/responsibilities
Preliminary review of study‑related documents received in the IRB office, including new studies, continuing reviews, amendments, and safety events.
Review and, where necessary, edit consent forms, protocol summaries, and requests for Waiver or Alteration of Consent and HIPAA Authorization to ensure consistency with federal regulations and Duke policy concerning human subjects research.
Determine if amendments, new studies, and renewals qualify for expedited review according to federal regulations.
Coordinate the sending of modification requests, review replies, and issuance of approval letters to research personnel.
Collaborate with one other Board Specialist to build and distribute monthly IRB meeting agendas.
Confirm attendance, arrange lunches (when in‑person meetings occur), maintain quorum counts, and provide administrative assistance to meeting members.
Record minutes of the convened IRB meeting.
Engage more extensively with researchers to answer questions regarding federal regulations and IRB submissions.
Assist Primary Reviewers prior to monthly meetings by answering regulatory or policy questions and providing required documentation.
Participate in educational presentations customized for individual therapeutic areas.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. They are not exhaustive.
Choose Duke. If you enjoy working collaboratively with research teams and serving as a trusted resource, we invite you to apply. Join Duke’s IRB team and help supportekra ethical, high‑quality clinical research through partnership, guidance, and service.
Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy‑related conditions), sexual orientation or military status.čky
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. The collective success depends on the robust exchange of ideas—an exchange that is best when the diversity of perspectives, backgrounds, and experiences flourishes. All members have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
#J-18808-Ljbffr