Clinical Trials Regulatory Lead

UCI; California (MO); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Sick and vacation time

Retirement savings plans

Job summary

UCI in California is looking for a Regulatory Affairs Coordinator to oversee the regulatory aspects of clinical trials. Responsibilities include managing multi-phase clinical research protocols, ensuring compliance with regulatory requirements, and maintaining effective communication with various stakeholders. Candidates should have a Bachelor's degree and 3-5 years of related experience, along with strong organizational skills and the ability to work independently. Benefits offered include medical insurance and retirement savings plans.

Qualifications

• Experience submitting IRB applications.
• Ability to maintain effective working relationships.
• Must demonstrate appropriate customer service skills.
• Proven organizational skills and attention to detail.
• Ability to analyze and solve problems independently.

Responsibilities

• Manage regulatory aspects of clinical trials.
• Ensure compliance with all regulatory requirements.
• Lead study-related meetings and manage documentation.
• Interact with regulatory agencies like IRB and FDA.
• Maintain clinical trial information in management systems.

Skills

Regulatory submissions

Communication skills

Organizational skills

Customer service

Problem-solving

Education

Bachelor's degree or equivalent experience

3-5 years of experience as regulatory affairs coordinator

Tools

Microsoft Office

Zoom

Job description

UCI in California is looking for a Regulatory Affairs Coordinator to oversee the regulatory aspects of clinical trials. Responsibilities include managing multi-phase clinical research protocols, ensuring compliance with regulatory requirements, and maintaining effective communication with various stakeholders. Candidates should have a Bachelor's degree and 3-5 years of related experience, along with strong organizational skills and the ability to work independently. Benefits offered include medical insurance and retirement savings plans.