Note: The job is a remote job and is open to candidates in USA. PSI CRO is a dynamic, global company in the Pharmaceuticals industry, dedicated to improving medical science and the quality of life. As a Senior Clinical Research Associate, you will ensure the success of clinical research projects by managing timelines, building relationships with clinical sites, and focusing on subjects' rights and data compliance.

Responsibilities

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup (if applicable)
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Supervise study activities, timelines, and schedules on the country level
• Be a point of contact for in-house support services and vendors
• Be involved in quality control, such as compliance monitoring and reports review
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Skills

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in the USA (5 years minimum)
• Experience in 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, Chron's, UC) is 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)
• Experience monitoring complex Oncology trials required; experience with radiopharmaceuticals and/or breast cancer preferred
• Experience monitoring GI studies (IBD, Chron's, UC) is preferred

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