IRB Regulatory Analyst
Job location: Miami, FL
Employment Type: Full-time
Posted data: 2020-10-15
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The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.
With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.
The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.
The Office of the Vice Provost for Research, Human Subject Research Office (HSRO), has a job opportunity for a seasoned IRB Regulatory Analyst position at the Medical Campus.
CORE JOB SUMMARY
The IRB Regulatory Analyst 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 Regulatory Analyst is a regulatory compliance professional that supports the Human Subject Research Office (HSRO) and the Institutional Review Boards (IRB). The IRB Regulatory Analyst manages the privileged and confidential institutional review and approval process of all proposed research activities involving human subjects. Additionally, the incumbent supervises day-to-day activities of the board-based pod.
CORE JOB FUNCTIONS
- Remains abreast of relevant federal regulations and their application.
- Oversees the accurate and timely processing, tracking, and filing of submissions.
- Communicates effectively with investigators, sponsors, and IRB Chair and members.
- Obtains and distributes information required for expedited review.
- Records meeting minutes in sufficient detail to document IRB deliberations.
- Documents communications with investigators, regulatory entities, and any others involved in the conduct of submitted research.
- Maintains an accurate and comprehensive database of reviewed and approved research.
- Maintains records of expedited reviews, risk determinations, and any other relevant activities.
- Maintains, files, and archives systems that allow access to open and closed studies.
- Maintains suspensions, administrative closures, and final report submissions for the board-based pod.
- Issues notifications of IRB actions to investigators and other appropriate entities.
- Ensures investigators are aware of due dates for submission of renewals and other reports.
- Ensures that information submitted by investigators is adequate for effective review.
- Advises investigators in the preparation of their applications and accompanying materials.
- Screens subject inquiries, resolves issues, and conveys results of interactions with subjects to investigators, sponsors, and IRB members.
- Serves as the IRB liaison during audits by regulatory entities or sponsors.
- Assists with the recruitment, training, and continuing education of IRB members.
- Ensures that the agenda is prepared and prioritized appropriately.
- Ensures that the necessary materials are provided during meetings.
- Ensures that a quorum is present and maintained during convened meetings.
- Conducts IRB meeting(s) or other pod-related activities.
- 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-inclusive and may be expanded to include other duties or responsibilities as necessary.
Bachelor's Degree in relevant field required.
Certification and Licensing:
IRB professional certification is highly preferred.
Minimum 3 years of relevant experience. Previous IRB and regulatory analysis experience is preferred. Any appropriate combination of relevant education, experience and/or certifications may be considered.
Knowledge, Skills and Attitudes:
- Knowledgeable in the IRB/HSRO functions.
- Ability to deal with high volumes and rigid deadlines.
- Familiarity with research ethics and methodologies and ability to conduct independent literature research (including Internet-based research) are required
- Ability to communicate effectively in both oral and written form.
- Ability to maintain effective interpersonal relationships.
- Commitment to the University’s core values.
- Ability to work independently and/or in a collaborative environment.
- Proficiency in computer software (i.e. Microsoft Office).
- Ability to accurately prepare and maintain records, files, reports and correspondence.
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.Job Status:Full timeEmployee Type:StaffPay Grade:c105