Study Start Up Associate role at ICON Strategic Solutions USA
Join ICON Strategic Solutions as a Study Start Up Associate II in San Diego, CA. This life science job focuses on oncology clinical trials, managing regulatory and site-level critical documents to ensure smooth study start-up and compliance with ICH/GCP standards.
Job Details:
- Job Title: Study Start Up Associate II – Oncology
- Location: San Diego, CA (Hybrid remote option available)
- Department: ICON Strategic Solutions, Study Start Up
- Employment Type: Full-Time, Office-Based
- Reports To: Study Manager / Team Lead
- Key Focus: Regulatory document management and clinical trial start up activities
- Industry: Life Science / Clinical Research
- Experience Required: Minimum 2 years in clinical research or regulatory affairs
About ICON Strategic Solutions:
ICON Strategic Solutions is a world-leading healthcare intelligence and clinical research organization. ICON fosters innovation, inclusion, and excellence, providing life science professionals opportunities to grow while contributing to groundbreaking oncology trials globally. Apply for more Life science jobs in the USA.
Educational Requirements for Study Start Up Associate role:
Bachelor’s degree in life sciences, biotechnology, pharmacy, or a related field
Key Responsibilities for Study Start Up Associate role:
- Collect, prepare, review, approve, process, and track regulatory and site-level critical documents required for study site activation.
- Accurately enter study start-up activities into tracking systems and communicate progress.
- Coordinate translations for study start-up documentation.
- Prepare, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF), including Global, Country, and Site-specific templates.
- Negotiate ICFs with study sites to ensure compliance with local and global requirements.
- Interact with Ethics Committees (EC), Institutional Review Boards (IRB), and Competent Authorities (CA) to obtain approvals.
- Assemble, review, and submit Critical Document Packages (CDP) to Central CDP Review Teams and Sponsors.
- Ensure Investigational Product (IP) release aligns with regulatory and Sponsor requirements.
- Maintain Trial Master File (TMF) documents, performing quality control checks before filing.
- Forecast submission and approval timelines, providing risk mitigation plans when needed.
Skills Required for Study Start Up Associate role:
- Strong understanding of oncology clinical trials and life science regulatory requirements
- Proficiency in ICH/GCP guidelines and local regulatory requirements
- Attention to detail and document management skills
- Effective communication and negotiation abilities
- Ability to work in a hybrid or office-based environment
Benefits of the Role:
- Competitive salary and global benefits package
- Various annual leave entitlements
- Health insurance options for employees and families
- Retirement planning and life assurance
- Work-life balance initiatives, including flexible benefits, gym memberships, childcare support, and subsidized travel
- Inclusive, supportive workplace culture promoting career growth
