Clinical Research Associate – Cross TA

This is a fully remote position, open to applicants in Illinois.

📋 Description

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

• Perform various site visits, which include selection, initiation, routine monitoring, and close-out.

• Ensure adherence to ICH-GCP guidelines, standard operating procedures (SOPs), and regulatory standards.

• Keep documentation current in the Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF).

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

• Oversee patient safety by ensuring prompt and accurate reporting of adverse events (AE), serious adverse events (SAE), and protocol deviations (PQC).

• Aid in the recruitment and retention of subjects at the site level.

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

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

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

• Help in monitoring site budgets and ensuring timely payments to sites when applicable.

• Collaborate with cross-functional teams including Clinical Trial Assistants (CTAs), Lead Trial Managers (LTMs), and Clinical Trial Managers (CTMs).

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related field, or a qualified Registered Nurse (RN).

• Must be eligible to work in the United States without the need for visa sponsorship.

• At least 2 years of on-site monitoring experience as a clinical research professional in the pharmaceutical or Contract Research Organization (CRO) sector.

• Experienced in monitoring across a variety of therapeutic areas.

• Strong knowledge of ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.

• Excellent communication skills, problem-solving abilities, and a collaborative team player.

• Willingness to travel up to 50% for on-site monitoring visits throughout the southeastern region; preference will be given to candidates residing in Illinois near major HUB airports for efficient regional travel.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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