Clinical Research Associate, CRA

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

📋 Description

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

• Carry out site selection, initiation, regular monitoring, and close-out visits.

• Ensure adherence to ICH-GCP, SOPs, and applicable regulations at the site.

• Maintain accurate documentation within CTMS and eTMF systems.

• Support and monitor training for site staff while keeping compliance records.

• Oversee patient safety and ensure timely and precise reporting of AE/SAE/PQC.

• Assist in subject recruitment and retention efforts at the site level.

• Manage drug accountability and ensure proper storage, return, or destruction.

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

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

• Help track site budgets and ensure timely payments as necessary.

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

⛳️ Requirements

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

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

• At least 2 years of on-site monitoring experience in the pharmaceutical or CRO industry.

• Experience in monitoring Phase I/II clinical trials is essential.

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

• Strong communication skills, problem-solving abilities, and a collaborative approach.

• Employment with ICON is dependent on possessing the legal right to work in the location of the role.

🏝️ Benefits

• Competitive base salary accompanied by performance-related incentives.

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

• Retirement and pension plans available.

• Life assurance and disability coverage provided.

• Employee assistance programs and resources for well-being.

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