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
Company Overview
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. It was founded in 1995, and is headquartered in Zug, Zug, CHE, with a workforce of 1001-5000 employees. Its website is https://www.psi-cro.com/.