Senior CRA1

IQVIA; Lisboa; On-site; EUR 40,000 - 58,000; Full time

Job summary

IQVIA in Portugal is seeking a Senior Clinical Research Associate I to oversee monitoring and site management for clinical studies, ensuring protocol adherence and data quality.

The role involves coordinating site visits, training site staff, tracking regulatory submissions, and maintaining TMF/ISF in line with GCP and local requirements. Strong communication, organizational, and Office skills are essential, with at least two years of on-site monitoring experience.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare field.
• Minimum 2 years of on-site monitoring experience.
• Good knowledge of applicable clinical research regulations, including ICH-GCP guidelines.
• Strong written and verbal English communication.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, and close-out) per contract and GCP.
• Coordinate subject recruitment planning and site engagement.
• Provide protocol-related training and maintain regular site communication.
• Evaluate site practices for quality and regulatory compliance.
• Create and maintain monitoring documentation, visit reports, and action plans.
• Support start-up activities and TMF/ISF filing in line with regulations.

Skills

On-site monitoring experience

Regulatory knowledge (ICH-GCP)

English communication

Project coordination

Microsoft Office

Time management

Financial management

Education

Bachelor's degree in a scientific discipline or healthcare field

Tools

Microsoft Word

Excel

PowerPoint

Job description

Job Overview

If you're passionate about clinical research and thrive in a site-facing role, this is an opportunity to contribute to the successful execution of clinical studies while ensuring the highest standards of quality and compliance. As a Senior Clinical Research Associate I, you will perform monitoring and site management activities to ensure sites conduct studies and report data in accordance with study protocols, applicable regulations and guidelines, and sponsor requirements.

Key Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice (GCP).
• Work with sites to adapt, drive, and track subject recruitment plans in line with project needs.
• Administer protocol and study-related training to assigned sites and maintain regular communication with site personnel.
• Evaluate the quality and integrity of study site practices and ensure adherence to study protocols and applicable regulations.
• Escalate quality issues as appropriate.
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution.
• Support start-up activities where applicable.
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained according to GCP and local regulatory requirements.
• Create and maintain monitoring documentation, visit reports, follow-up letters, and action plans.
• Collaborate with study team members to support project execution.
• Support subject recruitment planning on a site level where applicable.
• Support site financial management activities where applicable.

Requirements

• Bachelor's degree in a scientific discipline or healthcare field preferred.
• Minimum 2 years of on-site monitoring experience.
• Equivalent combination of education, training, and experience may be considered.
• Good knowledge of applicable clinical research regulations, including ICH-GCP guidelines.
• Good therapeutic and protocol knowledge.
• Proficiency with Microsoft Word, Excel, PowerPoint, and other relevant technology tools.
• Strong written and verbal communication skills, including a good command of English.
• Strong organizational, problem-solving, time management, and financial management skills.
• Ability to build and maintain effective working relationships with colleagues, managers, clients, and site personnel.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.

We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.

All information and credentials submitted in your application must be truthful and complete.

Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.

We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world.

We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere.

When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things.

Multifaceted thought processes spark innovation.

Multi-talented collaboration harnesses innovation to deliver superior outcomes.

Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.