Clinical Research Associate – Cross TA

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

📋 Description

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

• Carry out all varieties of site visits, which include selection, initiation, routine monitoring, and close-out.

• Ensure that the site adheres to ICH-GCP, SOPs, and regulatory guidelines.

• Keep documentation current in CTMS and eTMF systems.

• Aid and monitor site staff training while maintaining compliance records.

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

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

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

• 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 tracking site budgets and ensuring prompt site payments when applicable.

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

⛳️ Requirements

• A graduate with a 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.

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

• Experienced in monitoring across various therapeutic areas.

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

• A clear communicator, adept problem-solver, and a cooperative team player.

• Willing and able to travel up to 50% for on-site monitoring visits within the southeastern region; preference will be given to candidates residing in Georgia near major HUB airports to facilitate efficient regional travel.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and well-being programs that include 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.