Clinical Research Associate II
Hace 5 días
Madrid, Community of Madrid, España
PSI CRO
Jornada completa
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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.
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.