Study Start-Up Specialist: Regulatory & Trials Activation

Regulatory Jobs; Center Square (PA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive base salary

Health, dental, vision coverage

Retirement plan

Life and disability insurance

Employee assistance programs

Training and career development

Job summary

ICON Strategic Solutions is seeking a Clinical Operations Specialist to join our sponsor-dedicated team in advancing study start-up activities. You will lead regulatory submissions, drive approvals, and ensure compliant start-up processes across trials, contributing to patient access to innovative therapies.

The role requires 2+ years in clinical research or regulatory affairs, strong organizational skills, and the ability to collaborate with diverse teams. Expect travel around 5% as needed.

Qualifications

• Bachelor's degree in life sciences or related field.
• 2+ years in clinical research or regulatory affairs, with study start-up experience.
• Knowledge of regulatory requirements and ICH-GCP guidelines.
• Strong organizational and project management skills.
• Excellent communication and collaboration with cross-functional teams.
• Willingness to travel ~5%.

Responsibilities

• Lead the preparation and submission of regulatory documents, including CTAs, ethics submissions, and agency communications.
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive, accurate records of regulatory submissions, approvals, and correspondence.
• Provide guidance and support to study teams on regulatory requirements and best practices for study start-up.
• Participate in process improvement initiatives to streamline study start-up processes and increase efficiency.

Skills

Communication

Project management

Regulatory affairs

Travel willingness

Cross-functional teamwork

Education

Bachelor's degree in life sciences

Job description

ICON Strategic Solutions is seeking a Clinical Operations Specialist to join our sponsor-dedicated team in advancing study start-up activities. You will lead regulatory submissions, drive approvals, and ensure compliant start-up processes across trials, contributing to patient access to innovative therapies.

The role requires 2+ years in clinical research or regulatory affairs, strong organizational skills, and the ability to collaborate with diverse teams. Expect travel around 5% as needed.