Website Argonne National Laboratory
As the head of the Biological Safety Program, provide professional biosafety support services for management and research staff to maintain a safe and healthy working environment in R&D laboratories and programs utilizing biological materials. Provide guidance in the continuing improvement and implementation of Argonne’s Biosafety Program. Serve as the Biological Safety Officer/SME for the Laboratory, which includes selection and qualification of other biological safety SMEs to support directorates as needed.
As the head of the Human Research Subjects Program, ensure compliance with specialized federal regulations as part of research activities (for example, FDA, HIPAA, FERPA, DHHS/OHRP) and with additional sponsor requirements.
- Ensure researchers are complying with DOE, additional federal requirements and institutional policies and procedures.
- Serve as resource for managers and principle investigators regarding human research subject’s compliance.
- Manage the pre-review and follow up process for all IRB submissions.
- Understand, interpret, and implement Laboratory and federal regulations related to human research subject’s studies.
- Serve as a conduit between the IRB and the research team regarding IRB-mandated stipulations and determinations.
- Develop consistent methodology, practices and policies/procedures that foster and enhance compliance in research involving human subjects.
- Conduct routine assessments to ensure continued compliance with all federal regulations.Notify the research and operations community of important human subject protection issues as they arise and communicates changes in federal regulations that impact research process and compliance.
- Use coordination and communication skills to effectively negotiate and appropriately influence the ethical behavior of individual lab workers, principal investigators, and interdisciplinary research groups towards implementing best management practices.
Required Knowledge, Skills, and Experience:
- Ability to develop and lead program activities for all Laboratory activities concerning the use of human subjects and/or their derived protected personal/health information.
- Demonstrated knowledge of chemistry, biochemistry, and/or microbiology technology.
- Strong knowledge of human subjects research regulations including the IRB process.
- Ability to communicate effectively verbally and in writing including written proposals, papers, and reports.
- Skill in establishing and maintaining effective interpersonal relationships; handling conflict resolution, gaining cooperation of others, and negotiating matters of significance in a team environment.
- Excellent listening, presentation, and interpersonal skills required to enhance the commitment of all employees for a safe working environment
- Knowledge of Project Management disciplines including scope, schedule, cost, issue, risk, quality, and resource and communication management.
- Experience tracking, reporting, evaluating and controlling projects. Ability to think quickly when managing difficult situations.
- Strong organizational and time management skills including the ability to schedule, plan, and monitor program assignments and details.
- Ability to think creatively and solve complex problems.
- Ability to model Argonne’s Core Values: Impact, Safety, Respect, Integrity, and Teamwork.
To apply, visit the Argonne Careers page and search Requisition Number: 406592
To apply for this job please visit www.anl.gov.