IRB ANALYST III / 08-14545

Position Description:

The IRB Analyst III is responsible for coordinating IRB Office processes and/or team(s) of IRB staff made up of IRB Analysts I and II, and clerical support with the purpose of facilitating efficient and accurate processing of IRB submissions. The IRB Analyst III may also perform quality assurance activities on elements of the work flow processes. This position works closely with the Chair CPHS, the IRB Chairs and Vice Chairs and reports to the Assistant Director, IRB Operations. Additionally, the Analyst III position will provide support in the IRB Office by performing tasks within the submission workflow. JOB SPECIFIC RESPONSIBILITY / STANDARDS: 1. Team Leader: The Analyst III will work with one or more teams of Analysts and clerical staff to coordinate the following functions: • Workflow: responsible for the ensuring timely processing, review and disposition of protocols assigned to team, including, but not limited to: - Protocol Processing- IRB Meetings Preparation and Reporting- Responsible for ensuring the timely notification, processing, review and disposition of all continuing review activities including: unanticipated problems related to research, protocol amendments, protocol deviations and continuing review reports• Perform Quality Assurance Reviews of Analysts’ work and provides constructive feedback.• Maintenance of IRB Files,timely communication with investigators/designees regarding IRB submissionsand assists on special projects as needed.2. IRB Operations: Provide IRB Support by performing the following tasks: • Protocol Processing: responsible for the ensuring timely processing, review and disposition of assigned protocols- Perform screening/review of submitted protocols to ensure completeness and conformance with IRB SOPs- Ensure timely processing of protocols eligible for review using expedited procedures- Provide instruction and advice to faculty, staff and student researchers on the regulations and on preparation of applications.- Provide timely follow-up on IRB requests and correspondence to assure compliance• Meetings Preparation and Reporting- Prepare preparation of agenda for committee meetings in accordance with SOPs.- Prepare and distribute meeting minutes for comments after the meeting in accordance with SOPs and accepted timelines.- Correspond with investigators to provide the outcome of committee determinations and stipulations in accordance with accepted timelines- Review investigator responses to IRB Stipulations and determine the adequacy and completeness of investigator responses, requesting additional material or information in order to address concerns. - Work closely with, and in support of, the respective IRB Chair, Vice Chairs, reviewers and other members• Responsible for ensuring the timely notification, processing, review and disposition of all continuing review activities including: unanticipated problems related to research, protocol amendments, protocol deviations and continuing review reports• IRB Files- Enter specified data from new applications and all subsequent protocol events information in the IRB Database/ Management System.- Responsible for the maintenance and retention of all required IRB records, communications and other files3 Human Subjects Protection: Compliance and Oversight • Maintain a current understanding and knowledge of federal and state regulations, state and local law and CHOP IRB SOPs• Serve as a consultant to the IRB membership and the institution on matters related to IRB procedures and applicable federal regulations • Participate in institutional research educational activities related to IRB expertise and human subjects protections• Ensure that membership of the IRB membership meets IRB SOP requirements, assist in the identification, recruitment and appointment of new members • Assist in the coordination of IRB activities with other CHOP and University committees and research administrative offices • Participate in continuing education and national and/or regional organizations devoted to the promoting research ethics, the protection of human subjects • Help ensure appropriate legal input into IRB activities• Develop and maintain contacts among peers at other institutions, monitor on-going national discussions on regulatory and ethical issues4. Contacts with others • Function as a liaison within and between the IRB committees, investigators and their designees, and Research Compliance and research administrative staff • Communicate with federal/state regulatory offices, as appropriate and as required by the Director• Represent the Office in relevant forums in the Hospital. • Participate in all relevant institutional research educational activities related to human subjects protections and IRB operations• Attend professional meetings for the Office, as appropriate and necessary. KNOWLEDGE, SKILLS & ABILITIES • Skills and knowledge of federal regulations pertaining to research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to clinical investigators • Knowledge of clinical research and familiarity with medical terminology• Ability to interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies for discussion with the Committee and/or Committee Chair. • Excellent written and oral communications skills.• Ability to provide effective leadership to work group.• Demonstrated ability to work as a team member • Ability to work effectively with individuals at all levels of the organization.• Excellent time management skills with ability to independently prioritize, organize and efficiently deal with a multiple ongoing activities• Must be mature, self-motivated and responsible; must be able to initiate and complete routine and non-routine tasks• Familiarity MS Word required; experience with computerized databases and MS Windows operating system environment helpful.

Qualifications:

EDUCATION & EXPERIENCE • BA/BS degree (biology, psychology or other clinical research-related area) required; Masters or other advanced degree preferred; equivalent combination of experience and education will be considered.• Minimum of 3 – 5 years of experience in IRB administration, clinical research or other humans subjects protection-related job. Direct and obvious relevance to regulatory compliance and research with human subjectsand research with human subjects.REQUIRED CERTIFICATES/REGISTRATIONS CIP certification required within one year of hire