Clinical Research Associate

This is a fully remote position, open to applicants in Illinois, +3 more states.

📋 Description

• Act as the main liaison between investigation sites and the sponsor.

• Carry out various types of site visits, including selection, initiation, routine monitoring, and close-out.

• Ensure compliance of sites with ICH-GCP, SOPs, and relevant regulations.

• Keep documentation current in the CTMS and eTMF systems.

• Assist in tracking site staff training and maintaining compliance records.

• Monitor patient safety, ensuring prompt and accurate reporting of AE/SAE/PQC.

• Aid in subject recruitment and retention initiatives at the site level.

• Manage drug accountability and ensure appropriate storage, return, or disposal.

• Address data queries and promote timely, high-quality data entry.

• Record site progress and escalate risks or issues to the clinical team.

• Help track site budgets and ensure timely payments to sites (if applicable).

• Collaborate with cross-functional partners, including CTAs, LTMs, and CTMs.

⛳️ Requirements

• A graduate holding a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN.

• Eligible to work in the United States without the need for visa sponsorship.

• A clinical research professional with over 2 years of on-site monitoring experience in the pharmaceutical or CRO industry.

• Experienced in monitoring early development Phase I/II clinical studies across various therapeutic areas.

• Knowledgeable in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.

• Willing and able to travel up to 60% for on-site monitoring visits throughout the Midwest region; preference will be given to candidates residing in the Midwest region near major HUB airports.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.