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Human Research Ethics Board Manager
2 months ago
SierTeK Ltd. is actively seeking a qualified IRB Manager to oversee critical operations within the Air & Space Biosciences Division. This role is essential in ensuring that all research involving human subjects is conducted in accordance with ethical standards and regulatory mandates.
Key Responsibilities
- Act as the subject matter expert for the Institutional Review Board (IRB), providing guidance to Principal Investigators (PIs) and the leadership team.
- Oversee the preparation and evaluation of research proposals, ensuring compliance with federal regulations and ethical guidelines.
- Coordinate and manage IRB meetings, including the preparation of materials and documentation of attendance.
- Continuously monitor ongoing research projects to guarantee adherence to approved protocols and regulatory standards.
- Maintain comprehensive records of all IRB activities, including submissions, reviews, approvals, and communications.
- Document the IRB's decision-making process, including the resolution of any contentious issues and the specifics of approved modifications.
- Record detailed minutes of IRB meetings, including attendance, votes, and any conflicts of interest.
Qualifications
- A Master's degree is required, accompanied by a minimum of 5 years of relevant experience.
- In-depth knowledge of regulatory compliance and guidelines governing human subjects research, including the Common Rule and FDA regulations.
- Proven ability to manage multiple priorities with meticulous attention to detail.
- Capability to obtain and maintain a U.S. government security clearance.
- Strong communication and interpersonal skills, with proficiency in both in-person and remote interactions.
- Familiarity with various software applications and the ability to adapt to new technologies.
Preferred Qualifications
- Advanced degree in a relevant field such as public health or health sciences.
- Experience in military or defense research environments, understanding the unique challenges and requirements of these settings.
- A demonstrated history of managing research and development projects within the Department of Defense framework.
SierTeK Ltd. is committed to fostering a diverse workplace and values the contributions of all employees. We ensure that employment decisions are made based on qualifications and merit, free from discrimination.