PSI CRO
pharmaceutical
ClinicalResearchAssociateII
Neural analysis suggests this role is
optimal for mid candidates.
“Clinical Research Associate II at PSI CRO. Skills: Clinical monitoring, Site management, Regulatory support. Conduct onsite monitoring visits. Report onsite monitoring visits”
Industry & Context.
Query resolution
Ability to travel, Valid driver’s license
What They're Looking For.
Must Have
College/University degree in Life Sciences, 2 years independent on-site monitoring experience in Portugal, Full working proficiency in Portuguese, Full working proficiency in English, Full working proficiency in MS Office applications, Ability to plan, Ability to multitask, Ability to work in a dynamic team environment, Ability to travel, Valid driver’s license
Nice to Have
Experience in Oncology, Experience in Hematology
What You'll Do.
Conduct onsite monitoring visits
Report onsite monitoring visits
Involved in study startup
Perform source document verification
Perform query resolution
Responsible for site communication
Responsible for site management
Point of contact for support services
Point of contact for vendors
Communicate with project teams
Involved in site identification process
Support regulatory team
Prepare documents for study submissions
Participate in audits
Prepare for inspections
Participate in inspections
How You'll Work.
Team & Collaboration
Internal project teams; Support services; Vendors
Full Job 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. 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 * 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
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