Regulatory Affairs Manager

October 25

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The Geneva Foundation

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Federal Grant and Contract Management • Clinical Trials • Education • Federal Contracts • Military Medicine

201 - 500 employees

Founded 1993

🤝 Non-profit

⚕️ Healthcare Insurance

🔬 Science

Description

• Oversee assigned regulatory team staff • Oversee and submit regulatory lifecycle actions for all projects • Serve as principal administration regulatory liaison for projects • Develop and maintain recordkeeping systems and procedures • Oversee and prepare essential research documents • Oversee and perform submissions to the IRB • Advise study staff on good research practices • Provide audit support • Ensure program-wide research regulatory lifecycle compliance • Serve as programmatic subject matter expert (SME) for regulatory affairs actions • Oversee, prepare, and track regulatory lifecycle actions submitted to the Institutional Review Board (IRB) • Assist with the development of essential research documents such as protocols, informed consent documents, etc. • Create and maintain complete electronic regulatory binders for each study • Obtain and maintain personnel documents, including CVs and training completion reports • Promote safety and confidentiality of research participants • Stay up to date on all required human subjects research training • Develop and disseminate live trainings and educational materials • Advise study team members on good research practices

Requirements

• Bachelor’s degree or equivalent work experience required • Regulatory and IRB submission experience required • 3-5 years’ clinical research experience required • 3-5 years military/DoD research experience preferred • 1-2 years management/supervisory experience strongly preferred • 3-5 years’ non-profit, research, or healthcare experience preferred • Ability to provide strong leadership, innovative thinking, creative planning, and effective motivation skills required • Ability to exercise independent judgement in a fast-paced environment, manage multiple projects required • Must demonstrate high quality oral and written communication skills • Must be organized, detail-oriented, and possess a positive, professional demeanor • Must be flexible with changing priorities and able to communicate diplomatically

Benefits

• Medical, dental, and vision healthcare • Flexible Spending Account • Health Savings account, with employer contribution • Coverage for employees and family members including domestic partners • Short-and long-term disability • Employee Assistance Program • Life & ADD insurance • 403b retirement plan with generous employer match • Flexible leave options • 11 paid holidays per year • Up to 4 weeks of paid time off in a rolling year