Clinical Research Associate – Cross Therapeutic
Posted 5 days ago
Posted 5 days ago
This is a fully remote position, open to applicants in Illinois.
• Act as the main point of contact between investigational sites and the sponsor.
• Perform site selection, initiation, routine monitoring, and close-out visits.
• Ensure compliance of sites with ICH-GCP, SOPs, and applicable regulations.
• Maintain accurate documentation within CTMS and eTMF systems.
• Provide support for site staff training and manage compliance records.
• Monitor patient safety and oversee AE/SAE/PQC reporting.
• Assist in subject recruitment and retention efforts.
• Manage drug accountability, including storage, return, or destruction.
• Address data queries and ensure timely, high-quality data entry.
• Record site progress and escalate any risks or issues as needed.
• Help with site budgets and payment processes.
• Collaborate effectively with CTAs, LTMs, and CTMs.
• Bachelor’s degree in Life Sciences or equivalent, or a qualified RN.
• Must be eligible to work in the United States without visa sponsorship.
• Minimum of 2 years of on-site monitoring experience in the pharmaceutical or CRO sector.
• Experience in monitoring across various therapeutic areas.
• Proficient in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.
• Willing and able to travel 60% - 75% of the time for on-site monitoring visits throughout the Midwest region.
• Preference will be given to candidates residing in Chicago, particularly near major HUB airports.
• Competitive base salary along with performance-related incentives.
• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans available.
• Life assurance and disability coverage provided.
• Employee assistance programs and wellbeing resources offered.
• Opportunities for learning and development through structured training and career pathways.
Thermo Fisher Scientific
ICON plc
ICON plc
Clinical Outcomes Solutions
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