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|Sr. IRB Regulatory Analyst|
Company: University of Miami Health System
Location: Coral Gables, FL
Employment Type: Full Time
Date Posted: 10/15/2021
Expire Date: 12/15/2021
Job Categories: Education
Sr. IRB Regulatory Analyst|
The Office of the Vice Provost for Research and Scholarship, Human Subject Research Office (HSRO) has an exciting opportunity for a Sr. IRB Regulatory Analyst position at the Coral Gables Campus.
CORE JOB SUMMARY
The Senior IRB Regulatory Analyst supports IRB operations to protect the rights and welfare of human research subjects. The Senior IRB Regulatory Analyst manages the privileged and confidential institutional review and approval process of all proposed research activities involving human subjects. Additionally, the incumbent conducts expert review of proposed human subject research, including administrative review of studies using an external IRB and IRB review of studies using an UM IRB for multi-site studies.
CORE JOB FUNCTIONS
Conducts reviews of protocol and other submissions and communicates with researchers as it relates to regulatory deficiencies and University policies.
Provides QA or QC functions.
Assists with Project Management.
Creates and adheres to metrics-driven timelines.
Creates and presents research-related educational materials within and outside the University of Miami.
Prepares documents for submission to federal agencies.
Keeps abreast of current federal regulations and guidance documents, State laws, University of Miami policies and procedures as well as departmental SOPs and informs OVPRS leadership of changes.
Promotes quality improvement and best practice solutions.
Communicates with the research community, all OVPRS groups and external customers as applicable and provides consistent excellent customer service.
DEPARTMENT SPECIFIC JOB FUNCTIONS
Conducts preliminary review and evaluation of HSR submissions requiring administrative review, expedited reviews, and full committee reviews.
Determines whether a project meets the definition or requirements of HSR and makes recommendations as applicable.
Provides expert consultation and guidance to IRB team members and the research community.
Remains abreast of federal regulations and their application.
Oversees the accurate and timely processing, tracking, and filing of submissions and actions by the IRB.
Communicates effectively with investigators, researcher and their team members, sponsors, and IRB Chair and members.
Obtains and distributes information required for expedited reviews.
Records and distributes meeting minutes in sufficient detail to document IRB deliberations.
Ensures determinations, notifications, and documentation are compliant with applicable federal regulations, state law, ethical principles and University policies.
Documents communications with investigators, regulatory entities, and any others involved in the conduct of submitted research and advises on action items.
Maintains an accurate and comprehensive database of reviewed and approved research.
Maintains, files, and archives systems that allow access to open and closed studies.
Maintains suspensions, administrative closures, and final report submissions.
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 when possible, and conveys results of interactions with subjects to investigators, sponsors, and IRB members.
Serves as 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.
Maximizes submission reviews on agendas accordingly in conjunction with Biomedical Committees/ CIRB.
Contributes to ongoing cross training efforts to ensure depth and eliminate silos.
Ensures that necessary materials are provided during meetings to conduct an effective review.
Ensures that a quorum is present and maintained during convened meetings.
Conducts IRB meeting(s), or other related activities, and ensure meetings are in compliance with applicable law, rules and polices.
Keeps members apprised of their responsibilities regarding conflicts of interest.
Adheres to University and unit-level policies and procedures and safeguards University assets.
Serves as a Primary or Secondary Reviewer when applicable.
May be required to work nights and/or weekends, or work may need to be performed outside of regularly scheduled business hours (i.e. attendance at IRB meetings, preparation for IRB meetings, work related to regulatory review, etc.).
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. Master’s Degree preferred.
Certification and Licensing:
IRB professional certification is highly preferred.
Minimum 4 years of relevant experience. Previous IRB and regulatory analysis experience is required. 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 maintain effective interpersonal relationships
Ability to communicate effectively in both oral and written form and with sensitivity
Skill in collecting, organizing and analyzing data
Proficiency in computer software (i.e. Microsoft Office)