JOB OVERVIEW

We are seeking a dedicated and detail-oriented Clinical Research Regulatory Specialist to join our team. In this role, you will be responsible for overseeing various aspects of clinical trials, ensuring compliance with FDA regulations and quality assurance standards. Your expertise in project management and research will be crucial in driving the success of our clinical studies, particularly in the area of chemistry manufacturing controls.

REQUIREMENTS

• Proven experience as a Clinical Research Regulatory Specialist or equivalent position
• Bachelor’s degree in related field (e.g. life sciences, healthcare, regulatory affairs).
• Experience with electronic document management systems
• Experience working in Clinical Research IO (CRIO)
• Excellent communication and interpersonal skills
• Knowledge of industry’s legal rules and guidelines
• Proven experience in project management within a clinical research setting.
• Strong understanding of clinical trials, including design, execution, and regulatory requirements.
• Familiarity with compliance management processes related to clinical research.
• In-depth knowledge of FDA regulations governing clinical trials.
• Strong attention to detail with exceptional organizational skills.
• Excellent verbal and written communication skills to interact effectively with team members and stakeholders.

ADDITIONAL ELIGIBILITY QUALIFICATIONS

None required for this position.

Experience:

• Clinical Research Regulatory: 2 years (Required

RESPONSIBILITIES

• Manage and maintain regulatory documents in accordance with ICH/GCP and FDA guidelines.
• Collaborate with internal teams to ensure regulatory compliance throughout the research process.
• Develop and implement systems and processes to streamline regulatory operations
• Work independently to meet regulatory deadlines and milestones.
• Provide guidance and support to site staff on regulatory matters.
• Keep abreast of regulatory updates and industry best practices.

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee/ independent contractor for this job. Duties, responsibilities and activities may change at any time with or without notice.
If you are passionate about advancing medical research and have the qualifications we seek, we encourage you to apply for this exciting opportunity as a Clinical Research Specialist.
Job Type: Full-time
Pay: $55,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Application Question(s):

• Please highlight current or past clinical research regulatory experience, including any of the computer systems you may have worked in as part of your position.

Experience:

• Clinical Research Regulatory: 2 years (Required)

Work Location: Hybrid remote in Boise, ID 8370