Study Start Up Associate II
ICON · Blue Bell +1 more
Clinical OperationsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Study Start Up Associate II position supporting clinical trial initiation at ICON's Accellacare site network. The role involves preparing and managing regulatory documentation, coordinating stakeholder approvals, and ensuring compliance with regulatory requirements and GCP standards.
What they're looking for
- 1+ years clinical research experience in regulatory affairs or study start-up
- Strong knowledge of ICH-GCP and local regulatory requirements for clinical trials
- Experience at a clinical research site (preferred)
- Excellent organizational and project management skills with multitasking ability
- Bachelor's degree in life sciences, healthcare, or related field
- Strong communication and interpersonal skills for cross-functional collaboration
- Proactive approach with willingness to learn and develop new skills
What you'll be doing
- Prepare and submit regulatory documents including clinical trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain necessary approvals for study initiation
- Maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence
- Provide guidance to study teams on regulatory requirements and start-up best practices
- Participate in process improvement initiatives to enhance study start-up efficiency
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.