Clinical Research Associate II

Psi CRO; España; On-site; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Permanent contract

Full-time position

Competitive salary

Job summary

PSI CRO in Spain is seeking a Clinical Research Associate II to lead on-site monitoring across Phase II/III studies, ensuring data quality and regulatory compliance. You will build strong relationships with sites and investigators, manage communications with cross-functional teams, and support feasibility studies and regulatory submissions.

The role requires fluent English and Spanish, a Life Sciences degree with a Master’s in Clinical Trials, and at least 1 year of independent on-site

Qualifications

• A Life Sciences degree is required
• A Master’s degree in Clinical Trials is required
• At least 1 year of independent on-site monitoring experience in Spain
• Fluent in English and Spanish

Responsibilities

• Conduct SIV, RMV, COV on-site monitoring visits
• Perform CRF review, source data 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

On-site monitoring

Study coordination

SIV RMV COV visits

CRF review & source data verification

Query resolution

Site management

Vendor coordination

Communication of study progress

Travel readiness

Education

Life Sciences degree

Master’s degree 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.

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 beon 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

• 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

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