Clinical Start-Up Associate II: Regulatory & Contracts

11 Premier Research International LLC; Plymouth (NC); 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 is seeking a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team in North Carolina. You will help ensure timely regulatory submissions and site start-up deliverables across global trials.

You will coordinate with Project Managers, Clinical Leads, and Regulatory Start-up Managers, prepare local and central submissions, and review documents to ensure compliance with ICH/GCP and country-specific requirements.

Qualifications

• Undergraduate degree or international equivalent in a clinical, science, or health related field.
• 3+ years' direct study start up experience.
• Knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155.
• Proficient in development and review of Informed Consent Form templates and country-specific patient documents.
• Ability to work independently with minimal supervision and meet timelines.

Responsibilities

• Forecasts submission/approval timelines and ensures they are adhered to.
• May serve as primary point of contact during start-up on allocated projects.
• Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory submissions.
• Assists with EC/IRB or CA issue resolution at the country level.
• Reviews documents to ensure sponsor and investigator requirements meet local regulatory requirements and ICH/GCP guidelines.
• Negotiate site contracts and budgets with site and Contracts Lead until resolution.
• Quality review of informed consent and related patient documents.

Skills

Startup experience

Education

Undergraduate degree (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 in North Carolina. You will help ensure timely regulatory submissions and site start-up deliverables across global trials.

You will coordinate with Project Managers, Clinical Leads, and Regulatory Start-up Managers, prepare local and central submissions, and review documents to ensure compliance with ICH/GCP and country-specific requirements.