Duties include but are not limited to:
· Maintains current knowledge of Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations, guidance and standards. Reviews biomedical research studies for compliance with Federal regulations and Institutional policies and procedures. Interprets regulations and develop guidance documents for use by research department staff.
· Provides feedback, request additional information, resolve inconsistencies and clarify submission content (as necessary) to improve likelihood of obtaining committee approval to conduct or continue research at the time of review.
· Communicates with and guides investigators and research department staff on IRB requirements and procedures. Facilitates the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any.
· Analyzes each submission by applying appropriate regulations and regulatory requirements to determine whether it meets criteria for IRB review. Assigns the regulatory risk determinations based on the research plan, study phase and methodology. Makes determinations for expedited review classification or defers the submission to the full board review if expedited classification is found not to be appropriate. Reviews submissions to evaluate accuracy and to determine appropriate review category per regulations and guidelines. Resolves moderately complex issues involving more advance research into ethical questions. Reports serious non-compliance issues to the IRB Manager and Research Quality Assurance Manager.
· Under minimal supervision, manages regular and special meetings of the IRB. Organizes meeting agenda to meet distribution deadline, disseminates meeting agendas and packets, coordinates and attends meetings. Prepares and distributes meeting materials to IRB members, obtaining any needed information and material. Records the decision making process of the IRB in official minutes, capturing and documenting summarization of any controverted issues and their resolution, clearness about the actions of the IRB and exactly what the IRB approved, clear specification of any modifications required to obtain approval, degree of risk, specific required determinations, members present at the meeting, members entering and leaving the meeting, alternate members attending and for whom they are substituting, votes on actions, names of IRB members who abstain, names of IRB members who absent themselves due to conflict of interest, attendance at the meeting for each action, basis for IRB requiring change in research, basis for disapproval of research, the rationale for significant or non-significant risk determinations, approval periods, and other regulatory requirements. Facilitates discussion to ensure appropriate quality of IRB review and documentation of discussion and determinations in minutes (as required by federal regulation).
· Generates follow up reports and other high-level correspondence to communicate decisions of the IRB to investigators, sponsor and research central staff. Prepares and distributes decision letters and other appropriate documents on behalf of the IRB. Ensures that any post-meeting follow-up items are resolved in a timely manner.
· Maintains and monitors all clinical trial protocols, patient informed consent documents, etc. on the Clinical Trials Management System (CTMS) to ensure that these documents are current and accessible to investigators and site research staff. Distributes IRB approval documentation and post-meeting information to study sponsors, regulatory/safety staff and researchers (as appropriate).
· Manages and invoices all IRB services.
· Prepares, maintains and updates IRB files per FDA guidelines. Makes files available for audit inspections. Ensures file is continuously updated and prepared for audits. Assists the department in any Federal or Compliance audits.
Mandatory:
Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement.”During your employment with SCRI, you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.