Clinical Start-Up Specialist: Regulatory & Trial Activation

ICON Strategic Solutions; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate II to lead the initiation of clinical trials and ensure regulatory compliance for site start-up. You will work with sponsors, ethics committees, and regulatory agencies to advance trials and accelerate study activation.

You will build and maintain regulatory submissions, coordinate approvals, and guide study teams on best practices for start-up activities. Travel ~5% and a life sciences degree with 2 years’ experience are expected.

Qualifications

• Bachelor's degree in life sciences or related field is required.
• Minimum of 2 years in clinical research or regulatory affairs.
• Strong understanding of regulatory requirements and ICH-GCP guidelines.
• Excellent organizational and multitasking abilities.
• Strong communication and collaboration with cross-functional teams.
• Willingness to travel approximately 5%.

Responsibilities

• Lead submission of regulatory documents (CTAs, ethics submissions, regulatory agency communications).
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive records of regulatory submissions, approvals, and correspondence.
• Provide guidance on regulatory requirements and best practices for start-up activities.
• Participate in process improvements to streamline start-up processes.

Skills

Regulatory knowledge

Organizational skills

Project management

Communication

Interpersonal skills

Travel readiness

Education

Bachelor's degree in life sciences or related field

Job description

ICON Strategic Solutions is seeking a Study Start Up Associate II to lead the initiation of clinical trials and ensure regulatory compliance for site start-up. You will work with sponsors, ethics committees, and regulatory agencies to advance trials and accelerate study activation.

You will build and maintain regulatory submissions, coordinate approvals, and guide study teams on best practices for start-up activities. Travel ~5% and a life sciences degree with 2 years’ experience are expected.