Senior CRA1

IQVIA; Oeiras; On-site; EUR 42,000 - 64,000; Full time

Job summary

IQVIA is seeking a Senior Clinical Research Associate I to monitor and manage clinical sites, ensuring data quality and regulatory compliance across studies. You will conduct site visits, support start-up, and collaborate with study teams to drive successful execution.

Qualifications include a Bachelor’s in a scientific field and at least 2 years of on-site monitoring experience, with strong English communication and knowledge of ICH-GCP guidelines.

Qualifications

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

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
• Drive subject recruitment plans in line with project needs.
• Administer protocol and site training and maintain regular communication with site personnel.
• Evaluate site practices for quality and protocol adherence; escalate issues.
• Track regulatory submissions, recruitment, CRFs, data queries, and resolutions.
• Support start-up activities and TMF/ISF maintenance per regulatory requirements.
• Create and maintain monitoring documentation, visit reports, and action plans.
• Collaborate with study team to support project execution.
• Support site-level recruitment planning and site financial management where applicable.

Skills

Site monitoring

GCP/ICH-GCP

Clinical research

Communication (English)

Education

Bachelor’s degree in science/healthcare

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.