Qualifications

• Bachelor's degree in life sciences, nursing, clinical research, biomedical sciences, regulatory/quality, public health, or related field.
• 5+ years of experience in clinical research or clinical safety in a regulated healthcare environment.
• Experience supporting sponsor-led clinical studies, particularly for medical devices or diagnostics.
• Knowledge of FDA requirements, specifically 21 CFR Parts 803, 812, and 820.
• Experience in evaluating and documenting adverse events and safety issues.

Responsibilities

• Establish and implement clinical research safety processes for laboratory-developed tests and medical devices.
• Oversee safety planning and adverse event management for clinical studies.
• Conduct risk assessments and prepare safety reports and regulatory documentation.
• Collaborate with cross-functional teams to ensure compliance and participant safety.
• Develop safety processes, study documentation, and training materials.

Benefits

• 20 accrued PTO days annually plus 10 paid holidays.
• 401K with 100% company match up to 6%.
• Three health care plan options with company HSA contributions.
• Company stock grant upon hire.