Benefits of working at Temple University include:
Flexible work arrangement
Great Benefit package
Generous time off
4 Year Degree
Telecommuting is allowed.
Internal Number: 22004540
The Senior IRB Program Coordinator plays an integral role in managing the review of human subjects research at Temple University. The incumbent works with the university's research community and affiliated offices to help researchers meet compliance requirements for the approval of their research, while ensuring the research remains compliant throughout its life.
Temple is 7th in the nation among universities with the fastest growth in research in the past 10 years. Discoveries generated by Temple researchers span the university’s 17 schools and colleges, resulting in a diverse intellectual property portfolio that is reaching significant commercial milestones and delivering new solutions that impact communities.
The Office of the Vice President for Research (OVPR) collaborates with Temple University researchers and external partners to promote meaningful scholarship, uphold research integrity, and foster new discoveries that make a significant impact in communities.
This position is temporarily assigned a hybrid work arrangement (on-campus and remote), the duration of this hybrid work arrangement is at the discretion of Temple University and the Department.
Essential functions: Overall management of the IRB review and submission process including; identifying issues or concerns and developing potential solutions 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; Auditing IRB study files to ensure that the contents are accurate and complete and consistent with the database for quality assurance purposes; 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; 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 subjects in research; Performs other related duties as assigned.
Required Education & Experience: Bachelor's degree and at least four 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 (e.g., drafting and submitting IRB protocols as a study coordinator, grad student, etc.).
Preferred: *Master’s degree in a related field that included working with human subjects. *Experience with biomedical human research.
Required Skills & 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 *Demonstrated ability to work remotely, including fluency in cloud- or remote-based computer environments and video conferences. *Excellent interpersonal and customer service skills, along with the ability to effectively collaborate with a diverse constituent population, including remotely. *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.
The mission of Temple University's Human Research Protection Program (HRPP) is to protect the rights, dignity, and welfare of human subjects who participate in the research programs of the Temple System. Specifically, the HRPP has authority over all human subjects research conducted using any property or facility of Temple and under the direction of any employee, student, or agent of Temple. This authority extends to Temple University Hospital System employees, who must submit human subjects research to HRPP.