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Company: University of Miami Health System
Location: Coral Gables, FL
Employment Type: Full Time
Date Posted: 09/17/2021
Expire Date: 11/17/2021
Job Categories: Education
The Office of the Vice Provost for Research and Scholarship, Human Subject Research Office (HSRO) has an exciting job opportunity for an IRB Specialist at the Coral Gables Campus.
Salary ranges from $39,000 to $51,000<
CORE JOB SUMMARY
The IRB Specialist is instrumental in support of IRB operations to ensure it meets its primary responsibility of protecting the rights and welfare of Human Subject Research. The IRB Specialist is a regulatory compliance professional that supports the Human Subject Research Office (HSRO) and the Institutional Review Boards (IRB). Provides analytical support by screening incoming submissions, identifying the level of review necessary, identifying issues that will prevent approval and conducting administrative review of submissions that qualify for a determination of (1) exempt; (2) Not-human subject research; and (3) human subject research in which the University of Miami is not engaged. Makes recommendations based on experience and knowledge. Works with investigators and others to resolve issues identified during screening and analysis in a time sensitive manner.
CORE JOB FUNCTIONS
Conducts thorough and detailed pre‐review for all new submissions.
Evaluates and determines whether the submission is complete as outlined in the Investigators Manual and other applicable policies, federal regulations, institutional policies, and IRB requirements for approval.
Identifies issues that will prevent completion of the review such as training and ancillary review requirements.
Works with researchers to correct deficiencies and assist in correcting issues in submissions.
Determines the correct level of review: administrative, expedited or IRB Committee.
Completes administrative review of submissions that do not meet the definition of human subject research or meet the criteria for one or more of the exemptions found at 45 CFR 46.104, or for which the site under review is not engaged in human subject research.
Conducts review under the
Ensures determinations, documentation of determinations, and notifications regarding determinations, are compliant with applicable federal regulations, state law, ethical principles and University policies.
Communicates results of review to researchers and research team members in a timely manner that is understandable to individuals who may be unfamiliar with the multifaceted review requirements of IRB review and with sensitivity to the impact that non-favorable determinations might have on the individual.
Prepares draft agenda; schedules and attend IRB meetings, as directed.
Ensures that the materials necessary are provided during the meeting in order to conduct an effective review.
Assists team members with maintaining quorum.
Keeps members apprised of their responsibilities regarding conflicts of interest.
Prepares and distributes minutes as per
federal regulations and guidance, recording meeting minutes in sufficient detail to document IRB deliberations.
Provides expertise and guidance to the faculty, research staff, and Committee Members.
Documents communications with investigators, research team members, subjects, regulatory entities and others involved in the conduct of submitted research in compliance with applicable requirements.
Track and maintains an accurate, compliant and comprehensive database of research reviewed by the HSRO including expedited review, full committee review, required determinations, suspensions and terminations; and determinations of serious or continuing non-compliance or unanticipated problems involving risks to subjects or others.
Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inc
lusive and may be expanded to include other duties or responsibilities as necessary.
Bachelor’s Degree in relevant field.
Minimum 2 year of relevant experience. Any appropriate combination of relevant education, experience and/or certifications may be considered.
Knowledge, Skills and Attitudes:
Ability to accurately prepare and maintain records, files, reports and correspondence.
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.
Knowledge of medical terminology
Outstanding organization and prioritization skills
Proficient in Microsoft Office Suite (Word, Excel, Outlook)