Senior Clinical Research Associate

🕒 August 10

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on PSI CRO AG's careers page, not through a job board

First seen by Remote Rocketship August 10

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Logo of PSI CRO AG

PSI CRO AG

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Serve as the frontline of communication with project stakeholders • Ensure timelines, targets, and standards for clinical research projects • Build and maintain relationships with clinical sites and investigators • Conduct and report all types of onsite monitoring visits • Participate in study startup, when applicable • Perform CRF review, source document verification, and query resolution • Manage site communication and site activities • Supervise study activities, timelines, and schedules at the country level • Coordinate with in-house support services and vendors • Participate in quality control, including compliance monitoring and report review • Participate in feasibility research • Support the regulatory team in preparing documents for study submissions • Focus on subjects’ rights, safety, well-being, and data quality compliance

🎯 Requirements

• College/University degree in Life Sciences or equivalent combination of education, training & experience • Minimum 5 years of independent on-site monitoring experience in the USA • Experience with all types of monitoring visits in Phase I–III • Participation in clinical projects as a Senior Monitor • Experience monitoring complex oncology trials required • Experience with radiopharmaceuticals and/or breast cancer preferred • Experience monitoring GI studies (IBD, Crohn’s, UC) preferred • Full working proficiency in English • Proficiency in MS Office applications • Ability to plan, multitask, and work in a dynamic team environment • Communication, collaboration, and problem-solving skills • Ability to travel up to 80% • Valid driver’s license, if applicable • Must not require a work visa for employment or continued employment now or in the future

🏖️ Benefits

• Employees can work remotely • Career advancement opportunities • Hands-on involvement in every aspect of the study • Opportunity to lead challenging full-service projects on the country/regional level • Work for a company that puts its people first

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