Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
Job Description
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.
You will:
- 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
Qualifications
- 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)
Additional Information
Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.