Assistant Director, IRB

Assistant Director, IRB

Remote, Eastern Time Zone Hours

6-month contract, possibilities of extension/conversion

We are seeking an experienced Assistant Director to join our IRB team supporting decentralized clinical trials. In this role, you will work closely with study sponsors, clinical research sites, and other stakeholders to provide ethical oversight for decentralized clinical trials while overseeing a team of regulatory professionals.

Responsibilities:

• Review decentralized clinical trial protocols and informed consent documents to ensure ethical standards are upheld. This includes assessing potential risks to participants and adequacy of safety monitoring procedures.
• Lead and advise research teams on ethical considerations unique to decentralized trials, such as use of telemedicine, mobile applications, remote consent, and home health visits.
• Run convened IRB meetings to determine approval of proposed decentralized trials. Raise any concerns or required modifications to study teams.
• Conduct periodic reviews of ongoing decentralized trials to ensure continued compliance with ethical guidelines and protection of participant rights. Suspend or terminate approval if violations occur.
• Maintain current knowledge on regulations, guidance, and best practices related to ethics and participant safety in decentralized trials.

Requirements:

• Bachelor's degree in science, healthcare, or related field required; Master's degree preferred.
• At least 10-15 years' experience working in an IRB or clinical research ethics role required.
• In-depth knowledge of Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations for protection of human research subjects.
• Expertise in assessing unique ethical considerations in decentralized trial designs, including risks related to data privacy and autonomy.
• Excellent written and verbal communication skills to interact with diverse stakeholders.
• High attention to detail with exceptional analytical and critical thinking skills.
• Willingness to stay up-to-date on evolving regulations and trends in decentralized trials.
• Certified IRB Professional (CIP) certification required.
• Certified IRB Manager (CIMI) certification preferred.
• People Management experience