Clinical Research Associate II at PSI CRO

Porto, , Portugal -

Full Time

Start Date

Immediate

Expiry Date

14 Sep, 26

Salary

0.0

Posted On

16 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

On-site Monitoring, CRF Review, Source Document Verification, Query Resolution, Site Management, Study Startup, Regulatory Documentation, Audit Preparation, Oncology, Hematology, Portuguese Proficiency, English Proficiency, MS Office, Multitasking, Problem Solving, Collaboration

Industry

Pharmaceutical Manufacturing

Description

Company Description 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. Job Description 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.

Responsibilities

The CRA II is responsible for conducting onsite monitoring visits, performing source document verification, and managing site communications across Portugal. They also support study startup, regulatory submissions, and participate in audits and inspections.