Senior/Principal Clinical Research Associate (Midwest)

Atlas Search; United States; Presencial; USD 70 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Disability insurance

Resumo da oferta

A biotechnology company is seeking a Senior/Principal Clinical Research Associate in the Midwest, responsible for managing all aspects of clinical site activities. The ideal candidate will have a Bachelor's degree in a Life Science discipline and at least 3 years of direct site monitoring experience, along with a willingness to travel. The role offers full-time employment in a supportive environment with excellent benefits including medical and vision insurance, 401(k), and parental leave.

Qualificações

• 3+ years of direct site monitoring experience required.
• Willingness to travel up to 50-65%.

Responsabilidades

• Manage overall clinical site activities from start-up to close-out.
• Ensure compliance with regulatory requirements and study protocols.
• Serve as primary contact for clinical sites throughout the study.

Conhecimentos

Site monitoring experience

Clinical site management

Knowledge of ICH-GCP guidelines

Formação académica

Bachelor’s Degree in Life Science

Bachelor’s Degree in Nursing or RN

Descrição da oferta de emprego

Senior/Principal Clinical Research Associate (Midwest)

We are partnered with a biotechnology company seeking a Clinical Research Associate (Senior/Principal). The CRA will be responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start‑up, site initiation, patient recruitment, monitoring, site close‑out activities, inspection readiness and local regulatory and IRB/EC submissions of clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH‑GCP guidelines and all applicable regulatory requirements.

Responsibilities:

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites.
• Perform clinical site management and monitoring activities in compliance with principles of ICH‑GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines.
• Serve as primary point of contact for clinical sites through all phases from start‑up to close‑out of clinical studies.
• Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines.
• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance.
• Facilitate and support investigator site audits and/or inspection activities as needed.

Requirements:

• Bachelor’s Degree in a Life Science discipline required
• Bachelor’s Degree in Nursing or RN a plus
• Minimum 3 years of direct site monitoring experience required
• Must be willing and able to travel up to 50-65%

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Other, and Science

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

Benefits

• Medical insurance
• Vision insurance
• 401(k)
• Paid paternity leave
• Paid maternity leave
• Disability insurance