Clinical Research Associate II
About this role
Company Description
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.
Job Description
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.
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