Conduct onsite monitoring across Phase II and III clinical studies, manage site communications and study documentation, and coordinate with project teams, vendors, and support services.
Clinical Research Associate II
π Description
- Conduct and report onsite monitoring visits.
- Support study startup and feasibility research.
- Review CRFs and source documents, and resolve queries.
- Manage site communication and coordinate with support services and vendors.
- Communicate study progress to internal project teams.
- Support regulatory document preparation for study submissions.
π οΈ Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Independent on-site monitoring experience Argentina
- Experience in all types of monitoring visits in Phase II / III
- Experience in Oncology is preferred
- Full working proficiency in English and Spanish
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
Full job description
Company Description
PSI is a leading Contract Research Organization with more than 25Β years in the industry, offering a perfect balance between stability and innovation to both clients and employees.Β We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
- Conduct and report all types of onsite monitoring visits
- Be involved in study startup and feasibility research
- 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
- 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 Argentina
- Experience in all types of monitoring visits in Phase II / III
- Experience in Oncology is preferred
- Full working proficiency in English and Spanish
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
Additional Information
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
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