IRB Administrator/Coordinator
rtiint
 Durham, NC

RTI International is one of the world’s leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our more than 4,200 professionals provide research and technical services to governments and businesses over 40 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy, and the environment.

RTI International seeks an experienced human subjects protection professional to join the RTI Office of Research Protection as an IRB Administrator/Coordinator. The Office of Research Protection is responsible for ensuring compliance with all regulations related to the protection of human research subjects. This includes maintaining RTI's Federalwide Assurance (FWA) with OHRP, operating two IRB committees, conducting not human research and not engaged determinations, exemption determinations and expedited reviews, assisting RTI researchers in developing appropriate procedures for their studies, coordinating reliance agreements, providing post-approval IRB oversight, and conducting training with IRB members and researchers. The Office strives to maintain a collaborative relationship with researchers with the shared goal of conducting ethical human research.

Reporting to the Director of the Office of Research Protection and the IRB Manager, the IRB Administrator/Coordinator will have the following responsibilities.

Ensuring that submitted research is reviewed efficiently and consistent with

regulations by:

  • Having thorough knowledge of and the ability to apply DHHS and FDA federal regulations for the protection of human subjects; including familiarity with regulatory requirements for conducting research with vulnerable populations and certifying prisoner research to OHRP;
  • Reviewing IRB SOPs at least annually and proactively suggesting changes to the IRB Manager and IRB Director;
  • Assisting the IRB Manager in drafting new SOPs as needed;
  • Preparing written documentation of and implementing office work procedures to ensure standardization and consistency in the performance of IRB-related tasks;
  • Reviewing IRB office procedures periodically and proactively suggesting and making changes as appropriate to increase efficiency;
  • Auditing a sample of approved projects each year to ensure that approved procedures are being followed and that approved materials are in use.

Overseeing the accurate and timely processing, tracking, and filing of submissions to the IRB, assignment to Designated Reviewer and Committees, making exempt and not human research determinations, and recording determinations made by the IRB through the online submission system including:

  • Conducting Pre-Reviews of submissions to assure that adequate and required information is included in the submission such as addressing regulatory requirements for conducting research with vulnerable populations;
  • Conducting Pre-Reviews of consent forms for consistency with RTI consent templates and compliance with regulatory requirements including any information related to the regulatory criteria for waivers of consent/alterations of the consent process and/or waivers of written documentation of consent;
  • Making preliminary determinations about the level of IRB review (not research, exempt, expedited, full committee) required for a submission;
  • Conducting exempt reviews and making not human subjects research determinations;
  • Effectively communicating with RTI researchers about IRB requirements and additional information or changes needed in their submissions;
  • Distributing information to designated reviewers for exemptions and expedited reviews;
  • Ensuring that continuing review of research is conducted appropriately and in a timely manner;
  • Planning agendas for convened meetings and assuring that quorum is met for the meeting;
  • Ensuring that IRB members (or consultants) with the appropriate expertise (e.g., medical doctors or prisoner advocates) are involved in full committee reviews of medical and prisoner research;
  • Preparing materials and agendas in the online submission system for IRB member to conduct full committee reviews;

Maintaining accurate records of IRB actions by:

  • Attending convened meetings and recording notes about the committee’s deliberations;
  • Preparing detailed committee review documentation and minutes to document the committee’s deliberations for review and approval by the IRB Chair;
  • Preparing approval letters and related documentation.

Ensuring that appropriate parties are informed of the actions and findings of the

IRB by:

  • Informing the researchers of the actions by the IRB in a timely manner;
  • Distributing Committee review results to research team as soon as the Chair approves them;
  • Issuing approval letters to research teams;
  • Notifying other entities of IRB actions as appropriate;

Serving as an interface for research subjects, project teams, other IRBs., sponsors and regulatory agencies by:

  • Answering questions, supplying information, and offering advice and suggestions to project teams about human subjects issues and submissions;
  • Handling execution of IRB Authorization/Reliance Agreements with other IRBs, including those using the SMART IRB process;
  • Screening inquiries from research subjects and resolving issues when possible, and conveying results of interactions with subjects to project teams and IRB Chairs and Members as appropriate;
  • Assisting in the development and conduct of human subjects training for IRB Chairs and Members and for research staff;
  • Preparing updates and renewals for RTI’s Federalwide Assurance (FWA);
  • Assisting during audits by regulatory entities or sponsors.

Overseeing adequacy of IRB membership by:

  • Maintaining IRB membership logs and reviewing for proper committee composition, informing the IRB Director/IRB Manager of membership composition and status of individual members and whether changes are needed in membership;
  • Assisting the IRB Director and Chairs with the recruitment of new IRB Members and with conducting training of new IRB Members and with training for all Member;
  • Informing IRB Members of their responsibilities concerning conflicts of interest, maintaining documentation related to potential conflicts, and noting any conflicts in the meeting minutes;
  • Ensuring that a quorum is present and maintained during convened meetings;
  • Preparing committee rosters that are submitted to regulatory agencies.

As assigned, assisting the IRB Director and Manager with Office of Research Protection Administrative activities such as:

  • Preparing consultant agreements and ensuring their execution
  • Preparing and processing consultant invoices

Required Education/Experience

  • BA/BS required preferably in a research, scientific or related technical field—(MA/MS/MPH or equivalent would be preferred);
  • Certified IRB Professional (CIP)
  • At least 5 years of experience in IRB administration and/or human subject protection research oversight is required.
  • Extensive knowledge of DHHS federal human subjects regulations (The Common Rule, 45 CFR 46), related guidance, and appreciation of related regulatory, ethical and compliance principles;
  • Familiarity with other regulations and guidance (e.g., HIPAA, FDA (21 CFR 50 and 56)) that may be applicable in some studies conducted by RTI researchers;
  • Expertise in conducting or providing human subjects oversight for behavioral sciences and/or clinical trials and/or, investigator-initiated studies, contract and grant-supported research or related areas. Demonstrated ability to comprehend the research process and the various components. Thorough knowledge and experience with quantitative and qualitative research design;
  • Demonstrated characteristics: adaptability, agility, collaboration, collegiality, customer focus, ethics and integrity, and judgment,

Preferred Experience:

  • Prior experience as an IRB member or IRB office staff for an academic, government, or commercial organization
  • Experience conducting exempt and/or not research determinations—Previous experience as an IRB member
  • Knowledge or experience with IRB accreditation standards and processes;
  • Membership in national or regional human subject organizations
  • Experience with implementation and use of an online submission system