- Facilitates, manages, and triages the IRB protocol review process. This includes conducting pre-reviews; assessing submissions for completeness; evaluating studies for their potential risk level to participants; and using complex regulatory knowledge to determine the most expeditious and appropriate processing path to be followed for each application.
- Makes non-human-subjects research and exempt determinations based on expert knowledge of applicable regulations; assigns for review as appropriate non-exempt minimal risk research. Serve as an IRB member and conduct reviews and approvals of expedited submissions.
- Conducts accurate data entry and maintenance of all protocol review activities.
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- Consults with researchers and various University stakeholders and serves as an expert resource on IRB requirements and human subjects protection issues. Answers questions, concerns, and unexpected events in a timely fashion.
- Directs and coordinates the correspondence from the IRB office to investigators, reviewers, research participants, and other institutional IRBs as needed. Serves as a point of contact for the IRB office in multisite/inter-institutional research projects requiring IRB reliance agreements and facilitates their execution. Facilitating the execution of agreements may require use of supplemental electronic reliance management systems (e.g., SMART )
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Senior Research Compliance Specialist - Newark, United States - University of Delaware
Description
Senior Research Compliance SpecialistJob no: 500750
College / VP Area:
Research Office
Work type:
Staff
Location:
Newark
Categories:
Research & Laboratory, Full Time
PAY GRADE:
31E
CONTEXT OF THE JOB:
The research enterprise at the University of Delaware exceeded $325M in sponsored program expenditures in fiscal year 2023.
This included over 1400 proposals submitted and more than 700 new awards received totaling approximately $390M.
During fiscal year 2023, there were more than 2100 active awards, over 1700 Institutional Review Board submissions, over 100 animal protocols, more than 120 Material Transfer Agreements, and more than 5900 Effort Certification Reports.
UD's Research Office is charged with serving as an advocate for UD faculty, students and researchers as they pursue research and assist them to ensure compliance with all associated policies and procedures.
At UD all research involving human subjects, bio specimens and/or tissue samples from humans, and/or private identifiable data must be reviewed by the Institutional Review Board (IRB).
Under the general direction of the Director of Research Compliance (DRC), the Senior Research Compliance Specialist serves as an IRB Member and Administrator, is responsible for the day-to-day operations of the UD IRB office and the human research protection program.
The Sr.Research Compliance Specialist is accountable for the oversight, implementation, training, and management of policies and procedures pertaining to human subject research activities.
Tasks assigned to the Sr.Research Compliance Specialist include triaging, reviewing, analyzing, and monitoring active human research protocols; ensuring compliance with all federal regulations, IRB Standard Operating Procedures (SOPs), and institutional policies; providing technical support and regulatory guidance to the IRB, investigators, and their support staff; and providing education and training to faculty, researchers, and the IRB.
MAJOR RESPONSIBILITIES:
QUALIFICATIONS:
A minimum of 5 years of experience with a bachelor's degree in biomedical, behavioral, and/or social sciences, or 2 years of experience with an advanced degree is required.
Experience with biomedical, behavioral and/or social sciences research is desirable.
Certification as an IRB Professional (CIP) is desirable.
Advanced knowledge of federal regulations, state and local laws, plus institutional requirements related to human research subjects protection.
Demonstrated ability to interpret, apply and communicate federal and institutional guidelines, regulations, statutes, and institutional policies.
Experience implementing compliance programs and conducting regulatory audits.
Established decision-making skills and demonstrated analytical ability.
Demonstrated ability to make accurate and appropriate independent judgments issues.
Strong organizational and time management skills.
Ability to identify, prioritize, and pro-actively manage high volume workload, meet deadlines, and support multiple individuals simultaneously maintaining a high degree of accuracy and attention to detail.
Effective interpersonal and written/oral communication skills. Ability to communicate with individuals from different disciplines and backgrounds.
Highly collaborative and customer-service oriented.
Committed to fostering and supporting an inclusive culture where diversity is embraced, and equity is a core value.
Presentation skills and teaching/training experience developing educational content.
Proficient computer skills, including MS Office and database applications. Experience with electronic submission systems required.
Notice of Non-Discrimination, Equal Opportunity and Affirmative Action
The University of Delaware does not discriminate against any person on the basis of race, color, national origin, sex, gender identity or expression, sexual orientation, genetic information, marital status, disability, religion, age, veteran status or any other characteristic protected by applicable law in its employment, educational programs and activities, admissions policies, and scholarship and loan programs as required by Title IX of the Educational Amendments of 1972, the Americans with Disabilities Act of 1990, Section 504 of the Rehabilitation Act of 1973, Title VII of the Civil Rights Act of 1964, and other applicable statutes and University policies.
The University of Delaware also prohibits unlawful harassment including sexual harassment and sexual violence.Applications close:
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