- Reviews and analyzes modification submission documents (protocol, consent and other relevant documents) for completeness consistent with federal and state regulation, institutional requirements, and HRP policy, and communicates all identified deficiencies to investigators via electronic submission system clarification request. Ensures that submission accurately reflects all FDA and OHRP requirements including any IND/IDE issues and guides the PI with the application process if necessary
- Reviews and analyzes continuing review submission documents (protocol, consent and other relevant documents) for completeness consistent with federal and state regulation, institutional requirements, and HRP policy, and communicates all identified deficiencies to investigators via electronic submission system clarification request.
- When conducting pre-review for assigned submissions: Writes and relays clear and concise pre-review issues to PIs through official pre-review correspondence via email Conduct regular follow up with PIs on all outstanding issues resulting from pre review correspondence Work with researchers to revise submissions and prepare for final board review
- Evaluates all Full Board ongoing submission materials to determine consistency with IRB requirements for approval, including all NYUSoM Policies, applicable federal, state and local law and Good Clinical Practices
- Assigns reviewers for submissions reviewed, assignments must be made consistent with reviewers medical and scientific expertise where appropriate.
- Maintains rosters for each board, and updates OHRP and FDA consistent with regulatory requirements of each agency.
- Attends weekly board pre-meeting briefing and performs pre-review specialist responsibilities
- Works with the Full Board Post-Review Specialist in generating minutes for all Board meetings
- Provides vacation and sick leave coverage for the Full Board Post-Review Senior. Specialist as needed
- Attends debriefings as needed following board meetings to verify understanding of the determinations to be used to when covering the creation of minutes
- Provides guidance and assistance to the research staff to educate and assist them in IRB submission activities
- Ensures all decisions for submissions are relayed to PI through official IRB correspondence in electronic system and ensures any communications they have with research teams outside the system are recorded in an appropriate communication comments in IRB system
- Provides support and assistance for any additional work as required by the SSM
- Maintains Board Member evaluation process and all Board member requirements including collecting and storing CVs, tracking ongoing educational completion and attendance reports for annual stipends.
- Facilitates and conducts new Board member onboarding activities following Work Instructions
- Assists the SSM with special projects, policy formulation and protocol related issues
- Develops PowerPoint presentations and participates in education and training sessions for the research community. This will require working with the IRB Education Manager
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Institutional Review Board Specialist - New York, United States - NYU Langone Health
Description
We have an exciting opportunity to join our team as a Institutional Review Board Specialist.
Reporting to the Senior Scientific Manager Full Board (SSM) of the IRB, the Specialist is responsible for the efficient pre-review of full board modification and continuation submission action items from submission until board review within expected turnaround time, assists with minutes preparation, and performs initial study submission review as needed. The pre-review specialist also provides vacation and sick leave coverage to other Senior Specialists and a Full Board Sr Analyst.
Job Responsibilities:
Additional Position Specific Responsibilities:
Liaise with affiliate research committees and administrative staff (, CRSU, PRMC) to identify additional deficiencies and/or to determine that requisite approvals have been received. Conduct quality assurance reviews using weekly database reports and/or searches to determine status of workload. Provide organized and planned educational sessions for research community.
Minimum Qualifications:
To qualify you must have a Bachelors degree in a health related field. Solid command of human subject regulations and policies. Must exercise a high degree of independent judgment and discretion relating to research protocol issues. Superior organizational, analytical, time management, multi-tasking, and interpersonal communication skills required. Excellent verbal and technical writing skills, proficient use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.) Three + years experience in clinical research and/or IRB regulatory work.
Preferred Qualifications:
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) certification preferred OR to be obtained within 1 year of employment. Masters Degree.
Qualified candidates must be able to effectively communicate with all levels of the organization.
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