Clinical Research Associate II
AI Summary
Conducts on-site monitoring visits for clinical trials, verifies source documents and CRFs, manages site relationships, and ensures subject safety and data quality compliance.
About this role
Clinical Research Associate II
PSI is a leading Contract Research Organisation 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.
As a 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. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.
You will:
- Conduct and report SIV, RMV, COV onsite monitoring visits
- 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
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- Prepare and participate on audits and inspections
Qualifications
- A degree in Life Sciences and a Master’s degree in Clinical Trials are required
- At least 1 year of independent on-site monitoring experience in Spain
- Experience in all types of monitoring visits in Phase II and/or III
- Full working proficiency in English and Spanish
- 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
What We Offer:
- Stability, long-term cooperation
- Permanent contract, full-time job
- Competitive salary and benefit package
- Career development
- Unique combination of team collaboration and independent work
- Friendly and supportive colleagues
- Onboarding courses about clinical research industry
- Comfortable and well-established office
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.
Skills
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