Clinical Research Associate II
AI Summary
A Clinical Research Associate II conducts onsite monitoring visits, performs source verification and query resolution, supports study startup and site identification, and serves as a point of contact for sites and internal teams across therapeutic areas in Portugal.
About this role
Clinical Research Associate II
PSI is a leading Contract Research Organization with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
As a Clinical Research Associate at PSI you will be involved in improving patients' lives while enjoying a variety of monitoring tasks and working on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
Home-based in Portugal
You will:
- Conduct and report all types of onsite monitoring visits across sites in Portugal
- Be involved in study startup
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress
- Be involved in site identification process
- Support regulatory team in preparing documents for study submissions
- Prepare for and participate in audits and inspections
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience.
- At least 2 years of independent on-site monitoring experience in Portugal.
- Experience in Oncology, Hematology is a plus.
- Full working proficiency in Portuguese, English and MS Office applications.
- Ability to plan, multitask and work in a dynamic team environment.
- Communication, collaboration, and problem-solving skills.
- Ability to travel and valid driver’s license.
Additional Information
- PSI is a stable, privately-owned company, organically growing since 1995.
- We have an excellent reputation in the industry, having won the CRO Leadership awards several years in a row.
- Team collaboration is high on our agenda. Our aim is for employees to feel valued and heard in friendly and supportive teams.
- We offer extensive training programs, profound therapeutic area trainings, monitors training program, mentorship programs, interactive soft-skills trainings and more.
- PSI CRAs have an opportunity to work with different Sponsors on a variety of therapeutic areas.
Please provide your CV in English.
Skills
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