IRB Program Coordinator
DescriptionThe IRB Program Coordinator plays an integral role in the review of human subjects research at Temple University. The incumbent works with the university's research community and affiliated offices to foster a culture of compliance, while simultaneously meeting customer service needs.Responsibilities include the following: conducting review of IRB protocol submissions, continuing reviews, and amendments to approved studies; assisting Principal Investigators (PIs) in developing and submitting protocols and informed consent forms by offering expertise in study design, regulations regarding human subjects research, and navigating our submission process; identifying issues or concerns and working with the PI to ensure that the issues are resolved prior to the IRB committee meetings, thereby decreasing the length of the IRB review process of submissions; developing training tools for the research community to provide guidance on the preparation of IRB submissions; and auditing IRB study files to ensure that the contents are accurate and complete and consistent with the database for quality assurance purposes. The IRB Program Coordinator must maintain up-to-date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human n subjects in research. Performs other duties as assigned. Required Education and Experience:Bachelor's degree and at least three years of IRB experience and/or regulatory compliance experience in a research or clinical setting. An equivalent combination of education and experience may be considered. Required Skills and Abilities:*Demonstrated knowledge and understanding of complex federal regulations, ethical issues, institutional policies, and other federal agency requirements governing human subjects’ research.*Demonstrated computer skills, and proficiency with MS Word, MS PowerPoint, MS Excel or similar software programs.*Excellent interpersonal and customer service skills, along with the ability to effectively collaborate with a diverse constituent population.*Excellent verbal and written communication skills, including training skills.*Excellent problem-solving and critical thinking skills*Demonstrated organizational and time management skills, along with the ability to work under tight deadlines.*Demonstrated ability to be detail-oriented.*Demonstrated ability to work independently and as part of a team.*Must maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research. Preferred:*Master's degree in a related field.*Experience with biomedical human research.*Demonstrated knowledge of quality assurance or auditing functions. Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status protected by law. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and. employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at www.temple.edu. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety and can be found at: http://www.temple.edu/safety/asfr/ You may request a copy of the report by calling Temple University’s Campus Safety Services at 215-204-7900.
Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Student Faculty Center
Shift: Day Job
Employee Status: Regular