Clinical Research Manager

Responsibilities

• Oversee on-site research operations, including supervision of clinical trial conduct and staff performance.
• Manage regulatory oversight for clinical trials, ensuring compliance with FDA, OSHA, and Good Clinical Practices (GCP) guidelines.
• Lead recruitment efforts for new research studies and investigators.
• Manage the regulatory lifecycle with the Institutional Review Board (IRB), including initial submissions, amendments, and continuing reviews.
• Ensure participant safety and confidentiality while meeting sponsor enrollment and monitoring expectations.
• Document Adverse Events (AEs) and Serious Adverse Events (SAEs) according to sponsor requirements.
• Maintain accurate drug accountability and perform data quality checks in alignment with data management plans.
• Facilitate team meetings and serve as a subject matter expert for regulatory affairs and research practices.

Requirements

• Bachelor's degree or an experimental background.
• Experience with U.S. Food and Drug Administration (FDA) regulated clinical trials.
• 1-3 years of experience in staff or project management.
• Proficiency in Microsoft Office, specifically intermediate-level Excel skills.
• Strong oral and written communication skills with the ability to exercise independent judgment in fast-paced environments.

Preferred Qualifications

• 3-5 years of clinical research experience.
• 3-5 years of experience in non-profit, research, or healthcare sectors.
• Experience writing and submitting IRB protocols.

Benefits

• Medical, dental, and vision healthcare for employees and family members (including domestic partners).
• 403b retirement plan with a generous employer match.
• Flexible leave options, including up to 4 weeks of paid time off and 11 paid holidays per year.
• Health Savings Account (HSA) and Flexible Spending Account (FSA) with employer contributions.
• Eligibility for Public Service Loan Forgiveness (PSLF) due to 501(c)(3) status.
• Short-term and long-term disability, Life & AD&D insurance, and an Employee Assistance Program.

About the Company

The Geneva Foundation is a 501(c)3 nonprofit dedicated to advancing military medicine through research, development, and education. With a team of over 400 professionals worldwide, we work to ensure optimal health for service members and the communities they serve.