Clinical Start-Up Specialist II

Premier Research Group; United States; On-site; USD 64,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research in the United States is seeking a Site Start up Associate II to support regulatory submissions, site contracts, and budgeting within Clinical Monitoring and SSU. You will coordinate with PMs, Clinical Leads, and Regulatory Start-up managers on start-up activities and ensure compliance with local regulations.

The role requires a clinical/health-related degree, 3+ years of start-up experience, and strong knowledge of FDA/EU regulatory standards.

Qualifications

• Undergraduate degree or international equivalent in a clinical, science, or health related field

Responsibilities

• Forecasts submission/approval timelines and ensures adherence; primary contact for PM/Clinical Lead during start-up on assigned projects
• Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications; assists with EC/IRB issue resolution
• Reviews essential documents to ensure sponsor/investigator requirements and compliance with local regulations and ICH/GCP
• Contracts/budget negotiations with sites; submits to Contracts Lead until resolution and execution
• Reviews informed consent templates and patient documents for country-specific requirements

Education

Undergraduate degree or international equivalent in clinical, science, or health related field

3+ years' direct study start up experience

FDA Guidance Documents / EU Directives / Local Regulations / ISO14155

Country-specific regulatory requirements for clinical trials

Informed Consent Form templates and patient documents

Independent work with minimal supervision

Job description

Premier Research in the United States is seeking a Site Start up Associate II to support regulatory submissions, site contracts, and budgeting within Clinical Monitoring and SSU. You will coordinate with PMs, Clinical Leads, and Regulatory Start-up managers on start-up activities and ensure compliance with local regulations.

The role requires a clinical/health-related degree, 3+ years of start-up experience, and strong knowledge of FDA/EU regulatory standards.