Senior Study Start-Up Associate II Regulatory

ICON Clinical Research; United States; Remote; USD 70,000 - 95,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Job summary

ICON Strategic Solutions seeks a Study Start Up Associate II to lead regulatory document preparation and submissions for NA trials. You will coordinate approvals with internal and external stakeholders and maintain meticulous startup records to ensure compliant, timely study activations.

The role emphasizes collaboration across cross-functional teams, ongoing regulatory guidance, and involvement in process improvements to streamline study start-up activities and enhance efficiency.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Minimum of 2 years in clinical research or regulatory affairs with study start-up experience.
• Strong knowledge of ICH-GCP and local regulatory requirements for clinical trials.
• Excellent organizational and project management skills.

Responsibilities

• Lead preparation and submission of regulatory documents (clinical trial applications, ethics committee 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 to study teams for start-up activities.
• Participate in process improvements to streamline start-up processes and drive efficiency.

Skills

Regulatory affairs knowledge

Project management

Cross-functional collaboration

Attention to detail

Travel readiness

Education

Bachelor's degree in life sciences

Job description

ICON Strategic Solutions seeks a Study Start Up Associate II to lead regulatory document preparation and submissions for NA trials. You will coordinate approvals with internal and external stakeholders and maintain meticulous startup records to ensure compliant, timely study activations.

The role emphasizes collaboration across cross-functional teams, ongoing regulatory guidance, and involvement in process improvements to streamline study start-up activities and enhance efficiency.