The Human Subject Research Office (HSRO), Office of the Vice Provost for Research has an immediate opening for an IRB Specialist.
CORE JOB SUMMARYThe IRB Specialist is a regulatory compliance professional that supports the Human Subject Research Office (HSRO) and the Institutional Review Boards (IRB). The Specialist conducts regulatory pre-review on all submission action items from receipt until a determination is made. The Specialist evaluates all new submissions to determine consistency with federal regulations, Institutional policies and IRB requirements for approval and works with researchers to correct deficiencies in a proactive and supportive fashion. Records and compiles regulatory determinations at IRB meetings and manages the privileged and confidential institutional review and approval process for all proposed research activities involving human subjects to protect their safety, rights and welfare.
CORE JOB FUNCTIONS
- Uses independent judgment to review, analyze and assess, consent and other relevant documents, the completeness and accuracy of each submission submitted by Principal Investigator and their study teams.
- Conducts thorough and detailed pre-review for all new submissions to ensure compliance with code of federal regulations (45 CFR 46.109(e) and 21 CFR 56.108, Department of Health and Human Services and Food and Drug Administration), IRB Policy, Good Clinical Practice and FL State Laws.
- Assesses that submitted research is in compliance with submission requirements in Investigators Manual; applies sound/independent judgment, discretion and careful consideration of the regulations to garner and summarize circumstances for presentation to the UM IRB.
- Reviews, assesses and recommends to UM IRB submissions that qualify for expedited versus full Board review
- Verifies additional committee review by Conflict of Interest Committee (COIC), and other applicable ancillary or departmental review.
- Executes directives resolved by the UM IRB, including drafting and execution of determinations letters and applicable compliance directives or action items.
- Liaises with researchers to revise submissions and prepare for final board review.
- Ensures investigators and sponsors are informed of the actions and findings of the IRB by responding to requests for information, sending timely decision correspondence to appropriate parties, and meeting with the appropriate stakeholders regularly to assist with resolution of concerns.
- Maintains accurate records of IRB actions, compiles information, distributes reports, and responds to routine inquiries by researchers, and prepares signatory authority for certifications documenting IRB approval for funding agencies (federal and non-federal).
- Prepares agendas and ensures all materials are appropriately distributed and reports to committee as required, prepares final minutes and minor revisions to materials as directed, schedules and attends IRB meetings
- Collaborates, designs and implements improvements in communication, monitoring, training or enforcement of compliance standards.
- Provides guidance and assistance to the research staff to educate and assist them in IRB submission activities
- Develops training materials and participate in education and training sessions for research community or assist with special projects as needed.
- Develops and maintains templates for mailings and letters, and maintains accurate paper and electronic file.
- Conducts literature reviews and prepares reports for the IRBs on scientific, ethical, and existing and proposed regulatory topics.
- Other duties as assigned.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
Bachelor’s Degree in Business, Education, or related field.
- One (1) year of relevant work experience.
- Any appropriate combination of relevant education, experience and/or certifications may be considered.
Knowledge, Skills and Attitudes:
- Ability to define problems, collect and analyze data, establish facts and draw valid conclusions to solve problems, develop plans and reports, and plan initiatives
- Strong interpersonal skills and ability to collaborate well with others
- Ability to express ideas and information, clearly, concisely, verbally and writing. Excellent written and verbal communication skills
- Ability to manage multiple tasks, work under pressure, and meet deadlines in a high workload environment
- Strong time management skills with the ability to handle multiple projects at once
- Research ethics/methodologies: Familiarity with research ethics and methodologies and ability to conduct independent literature research (including Internet-based research) are preferred.
- Outstanding organization and prioritization skills
- Proficient in Microsoft Office Suite (Word, Excel, Outlook)
The University of Miami is home to some of the brightest minds in the world. We are committed to educating and nurturing students, creating knowledge, and providing service to our community and beyond. The University of Miami offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information-https://www.hr.miami.edu/careers/employment-laws-eo/index.html]]>