Research Compliance Coordinator III

The Tulane Human Research Protection Office (HRPO) administers the University's Human Research Protection Program (HRPP) and Institutional Review Boards (IRBs), which are charged with reviewing and monitoring human subjects' research under the auspices of the University. The employee in this position participates in all aspects of IRB communication and database management, paper and electronic file management, meeting preparation and post meeting activities.

The employee supports the research community with IRB protocol submissions and the use of IRB forms.

• Pre-Review IRB Submissions and Database Management:
  
  Pre-review protocols for completeness and compliance with regulations and IRB policies;
  Conducts evaluation of investigator’s response to identify potential issues for IRB reviewers;
  Assigns the appropriate category under federal under federal guidelines and forwards the protocol to a board member for expedited review – or recommend that it be reviewed by the convened IRB;
  Determines the most expeditious processing mechanism allowed for an application based on an understanding of the proposed research and an interpretation of appropriate guidelines.
  
  Meets with investigators and research staff to advise them on federal regulations and IRB submission requirements, and assists them as needed in the preparation of submission forms;
  Maintain documentation and records in accordance with federal regulations, sponsored-related, state and/or local laws and university requirements and ensure that all records are secured and properly archived;
  Maintain computerized IRB database.

Assists with the coordination of pre-Meeting preparation:

Arrange and monitor quorum at Board meetings, track IRB attendance, report significant absences under direction of the IRB Chairs and the HRPO Director/Assistant Director;
Prepare agendas for Board meetings; and prepare materials to distribute to Board Members or Chairs as instructed;
Coordinate the dissemination of information to Board members and the processing of responses/queries.

Assists with the coordination of post-Approval

Activities:

Compose and distribute correspondence to investigators on behalf of the Board, Director, and/or Chairs;
Prepare approval documentation in compliance with federal regulations, sponsor-related requirements, state and/or local law, and university policy;
Compose clear, concise and detailed correspondence to investigators to ensure that the concerns, rationale, and technical questions of the IRB are quickly and intelligibly communicated to the researchers.

Writes highly detailed meeting minutes to outline the issues analyzed by the committee, and accurately document the final determinations of the IRB.Determines when IRB requirements for approval have been met and issues approval documents.

Assists with regulatory compliance for the Post Approval Monitoring (PAM) Program which consists of monitoring and auditing IRB studies on a monthly basis and reports the findings to the IRB.

Educational Trainings/Compliance/IRB Membership:

Assists with educational seminars to the research community;
Help facilitate the orientation training and the continuing education of HRPO staff, IRB members, and the research community as instructed.

Assists with the development of newsletters and the HRPO/HRPP website.

Maintains the IRB Membership Binder on a monthly basis to ensure that it is kept up-to-date at all times. Oversees the industry-sponsored fees for all clinical trial IRB studies which include balancing the budgets for these types of research studies.

Attends committee meetings to provide technical support.

Assist with the coordination of the AAHRPP Re-accreditation packet.

Performs other duties as requested or required, whether or not specifically mentioned in this job description.

Minimum Qualification:

OR High School or equivalent with 6 years of related experience Preferred

Qualification:

Certified IRB Professional (CIP certification is highly desirable or will be required once eligible)

Tulane University is an equal opportunity educator and employer committed to providing an education and employment environment free of…