Catalyst Clinical Research
Catalyst Clinical Research is a specialized clinical research organization with a focus on oncology and multi-therapeutic functional service provision for the global biotechnology and biopharmaceutical industries. Through their Catalyst Oncology division, they offer full-service oncology clinical research support, tapping into an extensive site network and experienced global teams to aid cancer drug development. Meanwhile, Catalyst Flex provides specialized functional solutions across clinical operations, data management, biostatistics, and medical writing to strengthen and customize clinical trials. As a partner in drug development, Catalyst Clinical Research delivers flexible, customizable solutions to meet the diverse needs of biotech companies, emphasizing efficiency and innovation in research.
Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider
Senior Clinical Research Associate
December 20, 2024
Catalyst Clinical Research
Catalyst Clinical Research is a specialized clinical research organization with a focus on oncology and multi-therapeutic functional service provision for the global biotechnology and biopharmaceutical industries. Through their Catalyst Oncology division, they offer full-service oncology clinical research support, tapping into an extensive site network and experienced global teams to aid cancer drug development. Meanwhile, Catalyst Flex provides specialized functional solutions across clinical operations, data management, biostatistics, and medical writing to strengthen and customize clinical trials. As a partner in drug development, Catalyst Clinical Research delivers flexible, customizable solutions to meet the diverse needs of biotech companies, emphasizing efficiency and innovation in research.
Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider
📋 Description
• Monitor clinical trial programs and manage regional clinical trial sites. • Ensure compliance with relevant regulations including ICH/GCP and PhRMA guidelines. • Collaborate with clinical research team for site selection and study initiation. • Travel up to 80% within an assigned territory to monitor clinical trials. • Communicate status and resolve study related issues with site staff. • Assist with Investigator Meetings planning and FDA submission preparations.
🎯 Requirements
• Bachelor’s degree in a science or health-related discipline or equivalent of 7 years industry experience. • Minimum of 5 years’ experience in clinical research with direct site monitoring experience with a sponsor company or CRO and 3 years of recent oncology clinical trial experience. • Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and guidelines. • Strong organizational and time management skills and the ability to work independently. • Excellent communication and interpersonal skills. • Flexibility and ability to travel routinely to meet project requirements. • Strong knowledge of standard computer applications.
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