* JOB SUMMARY:

KEY RESPONSIBILITIES:

• Proficiently prepares and processes new research proposals, amendments, continuing review applications and adverse events preceding IRB Committee meetings, according to institutional/departmental policies and procedures and federal regulations.
• Independently performs comprehensive pre-review according to IRB Policies and Procedures. Reviews and verifies the ICD(s) for inclusion of the eight required elements and understandability for language appropriate to the target population. Identifies any vulnerable populations and verifies inclusion of appropriate special protections for these populations. Verifies the consistency of the grant, contract, sponsor or investigator protocol, ICD(s) and the Application for Human Research, Assesses the need for an expert consultation and/or literature search and initiates contact and follow--up with such reviewers.
• Creates and prioritizes agenda for committee reviews according to IRB Policies and Procedures, including assigning reviewers and /or the appropriateness o assigned reviewers according to areas of expertise. Verifies timely inclusion of expedited/exempt study approvals and study closures on agenda.
• Collates study documents for committee review packets. Pre-reviews packets for accuracy and completeness. Oversees distribution of agenda packets to committee members at least five business days prior to meeting.
• Independently and proficiently determines if the Request for Exemption application meets the exempt criteria and if additional documentation is required to support the claim for exemption. Independently and proficiently completes review and letter(s) of Exempt research applications. Facilitates completion within target goals as specified in IRB Measures of Success.
• Independently and proficiently performs Continuing Review notifications(s) at 8 weeks, 4 weeks, and 2 weeks prior to expiration date of protocol, according to IRB Policies and Procedures. Incorporates continuing review protocols on agenda prior to expiration date to determine approval status and to prevent lapse or suspension criteria. Interact with PI to obtain documents in an attempt to avoid suspension for lapse. Will achieve target goals as specified in IRB Measures of Success.
• Independently and proficiently determines if the Application for Human Research request for expedited review meets the expedited criteria and of additional documentation is required to support the claim for expedited review. Forwards expedited reviews to the appropriate committee reviewers and follows-up to assure completion. Facilitates completion within target goals as specified in IRB Measures of Success.
• Assists PI/study coordinator with the development of Application for Human Research and/or informed consent document(s).
• Independently and proficiently reviews and processes Adverse Events according to IRB Policies and Procedures. Evaluates adverse events to assure appropriate information is included in order for the Chair to make a determination. Obtains additional information when indicted. Facilitates completion within target goals as specified in IRB Measures of Success. Any Vanderbilt-related Serious Adverse Event (SAE) should be reviewed and submitted to the Chair within 48 hours of receipt. Understands definition of SAE according to federal regulations.
• Role models effective communication, collaboration, and directly manages conflict resolution, seeking appropriate leadership assistance when necessary.
• Proficiently facilitates and documents IRB Committee Meetings according to institutional and departmental policies and procedures and federal regulations.
• Ensures Committee meeting materials are ready for the Committee including motion prompters, reviewer sheets, nametags, files, and any catering needs.
• Facilitates IRB committee meeting to effectively utilize time and minimize interruptions to the flow of the meeting.
• Strong knowledge of federal regulations and IRB policies and procedures. Provides supporting regulatory guidance to assist in decision-making.
• Accurately documents key concepts and captures detail of controverted issues discussed during committee meetings as required by federal regulations. Able to differentiate between major and minor issues raised during discussions.
• Initiate and facilitate the incorporation of regulatory education within the meeting, including documentation in minutes. Coordinates with the education and compliance team regarding educational needs of the committee and the team.
• Facilitate voting on and documentation of previous meeting minutes.
• Assures performance and documentation of federal regulatory requirements according to IRB policies and procedures, including quorum, vote counts, level of risk, continuing review interval, etc.
• Proficiently processes and follows up of new research proposals, amendments, continuing review applications and adverse events succeeding IRB Committee Meeting according to IRB policies and procedures and federal regulations.
• Encourages all team members to actively participate in round table.
• Prepares minutes that accurately reflect committee discussions. Effectively interprets and summarizes committee discussion, reviewer comments and documents information in the minutes.
• Distributes comments within 1 business day and final minutes within 3 business days of meeting date. Performs critical analysis of final minutes for approval at next meeting.
• Independently and proficiently completes and distributes Committee Action Letters and Final Approval Letters within 3 business days of meeting date according to established policies and procedures, incorporating details of exact areas (e.g., page number, section number, paragraph, line) needing changes to minimize miscommunication and providing a rationale for the request to educate the investigator.
• Communicates with reviewer and/or members to clarify any vague points of discussion to facilitate Principal Investigator's understanding and response.
• Develops quality letters free of typographical letters, using good punctuation and grammar. Writes concise, accurate, organized documents which incorporate the necessary information while supporting good customer service skills.
• Ensures the integrity and security of IRB data, whether in paper or electronic format.
• Adheres to IRB Policies and Procedures relating to data entry of information.
• Accurately and completely enters data into IRB database insuring that all required data fields have been completed.
• Accurately and completely organizes and collates IRB files according to IRB Policies and Procedures.
• Adheres to institutional and departmental confidentiality and security policies and procedures.
• Proficiently performs routine database queries and report generation.
• Performs oversight and verification of database entries. Regularly monitors database views and files and follows-up with source to resolve outstanding issues.
• Provides training and acts as internal consultant to staff, committee members, and the VU research community. Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance own professional development.
• Utilizes the Belmont Report, OHRP regulations including subparts A, B, C, & D, the FDA regulations specifically related to drugs and devices, and IRB policies and procedures as a resource. Proficient in understanding and application of FDA and OHRP regulations and guidance documents. Familiar with key concepts in determination letters.
• Keeps abreast of and applies FDA and OHRP guidelines and institutional and departmental policies and procedures. Subscribes to OHRP listserve to receive updates of federal regulations and guidance in a timely manner. May subscribe to McWirb or other IRB-related discussion databases to keep up-to-date on current events, understanding the content is opinion not regulation.
• Develops educational tools and delivers in-services for staff, committee members, principal investigators, and the VU research community, one to two times yearly, or as requested in collaboration with the education and compliance team.
• Willingly serves on intra-departmental committees.
• Performs continuous self-assessment. Develop and achieve professional goals through action plans created to promote professional growth. Assumes responsibility for continuous learning. Demonstrates willingness to learn new skills.
• Demonstrates initiative in self-directed learning, as evidenced by attendance at professional development opportunities. Actively seeks new learning opportunities. Sees learning as part of work.
• Accepting of constructive criticism. Demonstrates a positive attitude in response to suggestions for improvement.
• Initiates and attends one formal regional/national conference per year and 7 informal educational opportunities per year. After attending conference, presents/educates staff on key topics or concepts from conference. Takes initiative to participate in poster sessions and presentations at local and regional conferences.
• Assists with development and revision of existing policies and procedures as well as development of new policies and procedures.
• Effectively applies analytical/problem solving skills and continuous quality improvement (CQI) tools and methods in daily work activities.
• Offers suggestion(s) for improvement of daily processes and procedures.
• Demonstrates initiative in completing tasks and solving problems. When concerns are identified, notifies the team leader offering solutions for their resolution.
• Can distinguish critical needs/problems from less urgent ones. Demonstrates ability to prioritize tasks and issues.
• Uses innovative thinking when developing alternative solutions.
• Routinely initiates and performs complex QA/QI audits. Provides analysis/summary of results and identifies alternatives for resolution of issues.
• Utilizes PDCA (Plan, Do, Check, Audit) format to document/implement CQI suggestions.
• Attends institutional CQI class.
• Develop poster sessions or presentations to educate others on QI projects and accomplishments.
• Assures PA tasks are completed according to IRB policies and procedures. Recognizes need for improvement/revision of departmental policies and procedures and takes the initiative to accomplish this by notifying the team leader of the potential issue, providing background information to support the change, and offering a draft to resolve the issue.
• Demonstrates characteristics of an effective team member.
• Communicates and models values and mission of VUMC and department.
• Establishes, supports and promotes ownership for team and departmental goals and willingly exerts extra effort when necessary to accomplish team and departmental goals.
• Creates and supports a climate of trust, openness and honest communication.
• Treats all team members as unique individuals with valuable resources and skills that enhance the team. Listens and understands other team member's point of view. Considers suggestions from others. Encourages appreciation and respect of diversity in the workplace.
• Recognizes and accepts additional responsibilities to support team/department by covering absences, assisting with increased workloads, sharing expertise and specific knowledge with team/coworkers, preparing for scheduled absences and delegating appropriately, following departmental/institutional policies on absences and leaving early.
• Attends institutional and/or departmental facilitative leadership class and applies learned concepts.
• Attends institutional and/or departmental team building class and applies learned concepts.
• Serves as a role model/mentor/coach for other members of work team. May function as a team leader/facilitator.
• Interacts with team members in a constructive manner by utilizing varied communication approaches and recognizing/respecting views on positions different from one's own.
• Recognizes areas of responsibility and takes charge of them. Takes responsibility for mistakes and learns from them.