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 is looking for a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma transform life-changing ideas into new medicines, devices, and diagnostics, while supporting regulatory submissions and document quality.

We seek an undergraduate degree and at least 3 years of direct study start-up experience, plus knowledge of FDA/EU/ISO regulations 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 and related processes.
• Familiarity with country-specific regulatory requirements for clinical trials.
• Proficiency in developing and reviewing Informed Consent Form templates and patient documents.
• Ability to work independently with minimal supervision and meet timelines.

Responsibilities

• Forecasts submission/approval timelines and ensures adherence, with contingency plans for delays.
• Prepares and submits Central EC/IRB, Local EC, RA and other local submissions as required.
• Gathers essential documents and ensures sponsor/investigator requirements meet regulatory standards.
• Negotiate site contracts and budgets with sites, under supervision, through to execution.
• Reviews informed consent and patient documents, adapting templates per country requirements.

Skills

Study start-up experience

Regulatory knowledge

Informed Consent development

Independent work

Project coordination

Education

Undergraduate degree in clinical/science/health-related field

Job description

Premier Research is looking for a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma transform life-changing ideas into new medicines, devices, and diagnostics, while supporting regulatory submissions and document quality.

We seek an undergraduate degree and at least 3 years of direct study start-up experience, plus knowledge of FDA/EU/ISO regulations and country-specific requirements.