Clinical Research Associate II

Psi CRO; Madrid; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Competitive salary

Team collaboration

Friendly colleagues

Onboarding courses

Well-established office

Job summary

PSI is a leading Contract Research Organisation delivering quality and on-time services across therapeutic indications. The Clinical Research Associate II will manage site relationships, ensure data integrity, and support regulatory submissions.

Role focuses on patient safety, data quality, and collaboration with internal teams and vendors in a dynamic Spain-based environment. Travel and bilingual English/Spanish communication are required.

Qualifications

• Degree in Life Sciences and a Master's in Clinical Trials are required.
• At least 1 year of independent on-site monitoring experience in Spain.
• Experience in Phase II and/or III monitoring visits.
• 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.

Responsibilities

• Conduct and report SIV, RMV, COV on-site 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 in audits and inspections.

Skills

MS Office

Communication

Teamwork

Travel

MS Office

Project planning

Multitasking

Communication

Team collaboration

Willingness to travel

Education

Bachelor's in Life Sciences

Master's in Clinical Trials

Tools

MS Office

Job 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 reportSIV, RMV,COVonsite 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 participateon audits and inspections

Qualifications

• A degree in Life Sciences and a Master's degree in Clinical Trials are required
• At least 1yearof 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 andSpanish
• 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:

• Competitive salary and benefit package
• 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 andtake your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.