Senior Clinical Research Associate
PSI CRO
Summary
As a Senior Clinical Research Associate you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects' rights, safety and well-being and quality of data compliance.
Job description
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
Requirements
- 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, Crohn'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)
Company overview
PSI CRO is a leading global contract research organization (CRO) specializing in full-service clinical development for pharmaceutical and biotechnology companies. Founded in 1995, PSI has established itself as a prominent player in the clinical research industry with operations spanning across North America, Europe, Asia, and Australia. The company focuses on delivering high-quality clinical trial services with particular expertise in oncology, central nervous system disorders, infectious diseases, and rare conditions. PSI's operational model emphasizes therapeutic expertise, operational excellence, and a patient-centric approach to clinical research. With a team of experienced professionals, the company manages all phases of clinical development from study design and protocol development to regulatory submissions and post-marketing studies. PSI is known for its efficient study execution, robust quality management systems, and commitment to accelerating drug development timelines while maintaining rigorous scientific standards.