Sr. Institutional Review Board Analyst

at  Morehouse School Of Medicine

Responsible for coordinating and reviewing caseload of applications related to human subjects research projects submitted for Institutional Review Board (IRB) analysis, maintaining the data archiving system and supporting the research community.

MINIMUM QUALIFICATIONS

• Bachelor’s degree, four to five years of related experience or an equivalent combination of work experience and education, training, and IRB related experience. Requires CIP certification and extensive knowledge of complex Federal, State and Local regulations and human subjects’ research. Excellent communication skills and computer skills to include MS Office Suite (Excel, Word, PowerPoint, and Access).

EEO STATEMENT SUMMARY

Morehouse School of Medicine is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Georgia State laws, regulations, and executive orders regarding non-discrimination and affirmative action. Morehouse School of Medicine does not discriminate on the basis of race, age, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, or gender identity or expression.
Job Duties

PRE-EMPLOYMENT/EMPLOYMENT REQUIREMENTS

All offers of employment are contingent upon successful completion of all pre-employment screenings.
Immunization

IMMUNIZATION REQUIREMENTS

It is MSM’s Immunization policy that all Prospective Employees are required to provide proof that they are vaccinated against COVID-19 prior to commencement of employment. If employment will commence during Flu Season, MSM requires all individuals to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless granted an exemption. Failure to provide proof of vaccination for any required vaccines or obtain an exemption from MSM will result in rescission of a candidate’s offer of employment or disciplinary action up to and including termination.

Leads the Reliance Team under the direction of Management:

• Acts as the liaison between the local investigator/staff and participating sites.
• Provides review of Local considerations for studies as outlined in the terms of the reliance agreements.
• Performs administrative review of and processing of documents from participating institutions; coordinates IRB review when serving as the single IRB.
• Assists in monitoring activities to ensure all regulatory and compliance requirements are met, protocol files are maintained, and responsibilities of reliance agreements are being followed.
• Screen and processes new research proposals and amendments applications according to institutional and Institutional Review Board (IRB) policies and procedures and federal regulations.
• Screens and processes continuing review applications according to institutional and IRB policies and procedures and federal regulations.
• Offers guidance to study teams on the applicable regulations and policies, on how to prepare quality IRB submissions, including the preparation of protocol and informed consent documents, and how to navigate the eIRB system.
• Independently provides education to the MSM research community in the form of outreach presentations and/or webinars in topics such as reportable events, IRB submission and informed consent process. Attends continuing education offerings sponsored by or recommended by IRB leadership. Facilitates staff meetings on a rotating basis and disseminates staff meeting minutes. Drafts and revises SOPs (collaborating with others as needed); contributes significantly and promptly to the development and revision of SOPs.
• Contributes to training of new staff members as assigned. May serve as IRB member for designated reviews (expedited and/or Privacy Board reviews) and/or as an advisor on regulatory and policy matters at IRB Committee meetings.
• Collaborates with colleagues, as needed, to ensure that all applicable institutional approvals and external IRB reliance agreements are in place before finalizing MSM IRB approval.
• Ensures the integrity and security of IRB data, whether in paper or electronic format. Adheres to institutional and departmental confidentiality and security policies and procedures.
• Recognizes and accepts additional responsibilities to support team and 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 and institutional policies on absences and leaving early.
• Is responsible for specialized handling of certain types of studies (e.g. Sponsor-Investigator studies, central IRB-reviewed studies) which may require collaboration with other compliance offices and fellow assigned IRB staff and adherence to specialized SOPs and checklists.
• Depending on assignment, may also be responsible for the following: Meeting Facilitators: Proficiently facilitates and documents IRB Committee Meetings according to institutional and IRB policies and procedures and federal regulations; under oversight of Team Lead/Director, may assist with recruitment and onboarding of members; maintains OHRP roster; monitors adequacy of membership in terms of diversity, expertise and number; manages member performance evaluations, oversees recruitment and appointment of new members, and member training and continuing education; or delegates aspects of the above.
• Is responsible for working with Team Lead/Director to determine priorities and develop quality improvement issues for the facilitator team. Processes study submissions, as needed. QA/Education Team: Leads and/assists with QA/QI external activities, preparing the report after the audit; manages SOP portfolio for the IRB office; performs QA/QI internal activities; assists with outreach program and IRB website management; assists with IRB member education.
• Under supervision of Staff Leadership, develops, directs, and implements compliance program components including protocol and consent form review, record keeping, monthly and annual reporting, program evaluation and other compliance issues that meet the applicable government and local regulations and the institution’s policies and practices.

Performs related responsibilities as required.