Job Information
Alameda Health System IRB Program Manager in Oakland, California
IRB Program Manager
Oakland, CA
Legal and Compliance
SYS Compliance
Full Time - Day
Req #:41453-30675
FTE:1
Posted:Yesterday
Summary
SUMMARY : Responsible for providing administrative oversight, support, and sufficient resources to maintain efficient Institutional Research Board (IRB) operations. Assists researchers in adhering to IRB requirements, federal and state regulations, state law, AHS policies, and the ethical principles that apply to human research projects. Investigates and resolves issues of noncompliance.
DUTIES & ESSENTIAL JOB FUNCTIONS : NOTE: Following are the duties performed by employees in this classification. However, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification.
Manage the day-to-day functions of AHS Human Research Protection Program (HRPP) and optimize resources to maintain efficient IRB operations.
Serve as the IRB subject matter expert to the Research Department, Principal Investigators (PIs), IRB members, and other stakeholders.
Ensure the preparation and review process for proposals which include pre-review assessments, review coordination with IRB members, and protocol requirements to PI's; ensure all submissions adhere to compliance with the appropriate federal and state regulations, institutional policies, and AHS IRB SOPs.
Continually monitor ongoing research efforts to ensure compliance with IRB-approved protocols and regulatory requirements.
Determine whether research projects are exempt from further review, review and approve certain research projects on behalf of the IRB as a designated reviewer.
Correspond with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered.
Prepare documents for deliberation at IRB meetings, attend IRB meetings, prepare meeting minutes, and communicate IRB determinations and actions to researcher.
Develop and participate in training and educational activities on human research protections that are presented to researchers and IRB members.
Provide guidance to researchers, IRB members, and other stakeholders on the use of the Research Suite Module.
Serve a critical role as liaison, facilitate meetings between project stakeholders and leadership, and complete and maintain documentation for projects and deliverables, and monitor approved human research projects.
Maintain active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development.
Educate the members of its research community in order to establish and maintain a culture of compliance with federal regulations and institutional policies relevant to the protection of human participants.
Ensure that changes in approved research, during the period for which IRB approval has already been given, are not initiated without IRB review and approval, except when necessary to eliminate apparent, immediate hazards to participants.
Ensure prompt communication of IRB proposed changes in a research activity to the Research Department.
Ensure prompt reporting as appropriate to the institutional officials, OHRP, and any sponsoring federal agency of: a) any unanticipated problems involving risks to participants or others; b) any serious or continuing non-compliance with the regulations or requirements of the IRB; and c) any suspension or termination of IRB approval for research.
Ensure that IRB records are being maintained per federal regulations and that the records are accessible, upon request, to authorized federal officials.
Oversee procedures for the retention of IRB records and documents for at least three (3) years past completion of the research activity.
Collaborate with relevant stakeholders related to reliance agreements.
Maintain current knowledge of human research protection guidance and regulations as they evolve. Stay current on emerging issues. Monitor federal regulatory websites and other research-related resources so as to stay current with regulatory changes in human research protections guidelines and policies.
Other duties as required.
MINIMUM QUALIFICATIONS :
Required Education: Bachelor's degree or combination of education and relevant experience.
Required Experience: 3 or more years of experience in IRB procedures and processes.
Preferred Licenses/Certifications: Institutional Review Board professional certification desirable.
Alameda Health System is an equal opportunity employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military background.