Remote Site Start-Up Associate II: Clinical Trials

Premier Research Group; Northern (KY); Remote; USD 64,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team. This remote, United States-based role supports biotech, medtech, and pharma clients in starting up sites for clinical trials.

You will manage regulatory submissions, site contracts, and informed consent documents across countries, ensuring adherence to ICH/GCP and sponsor requirements. The ideal candidate has 3+ years startup experience and a clinical/science background.

Qualifications

• Undergraduate degree in clinical/science/health related field.
• 3+ years direct site start-up experience.
• Strong knowledge of regulatory requirements (FDA/EU/ISO14155).

Responsibilities

• Forecasts submission/approval timelines and ensures adherence; provide contingency plans and escalate as needed.
• Prepare and submit EC/IRB, Local EC, RA submissions and other local approvals.
• Review essential documents to ensure sponsor and investigator requirements meet ICH/GCP guidelines.
• Negotiate site contracts and budgets with site and Contracts Lead until execution.
• Review and adapt informed consent templates and other patient documents per country requirements.

Skills

Startup experience

Regulatory knowledge

Informed consent documents

Education

Undergraduate degree in clinical/science/health

Job description

Premier Research is seeking a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team. This remote, United States-based role supports biotech, medtech, and pharma clients in starting up sites for clinical trials.

You will manage regulatory submissions, site contracts, and informed consent documents across countries, ensuring adherence to ICH/GCP and sponsor requirements. The ideal candidate has 3+ years startup experience and a clinical/science background.