Conduct onsite monitoring across clinical studies, oversee site communication and study progress, review clinical data, resolve queries, and support study startup and regulatory submissions.
Clinical Research Associate II (Contract based)
📜 Description
- Conduct and report onsite monitoring visits across clinical studies.
- Support study startup, feasibility research, and regulatory submission preparation.
- Review CRFs and source documents, and resolve data queries.
- Manage site communications and relationships with investigators.
- Oversee country-level study activities, timelines, and schedules.
- Coordinate with in-house support teams and vendors, and contribute to quality control.
🛠️ Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- A minimum of 1 year of independent on-site monitoring experience in Portugal
- Experience in all types of monitoring visits in Phase II and/or III
- Full working proficiency in English and Portuguese
- 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
Full job description
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
As a Contract Clinical Research Associate II, 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.
Home-based (freelance)
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
- 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
- A minimum of 1 year of independent on-site monitoring experience in Portugal
- Experience in all types of monitoring visits in Phase II and/or III
- Full working proficiency in English and Portuguese
- 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
Additional Information
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
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