Experienced Clinical Research Associate, Multi-Sponsor, France

IQVIA; Paris; Hybride; EUR 55 000 - 85 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Monitoring professional to conduct site visits in accordance with the study protocol, GCP and regulatory requirements. You will coordinate with experienced staff and manage monitoring activities across assigned sites.

Responsibilities include training site staff, maintaining TMF and ISF, tracking regulatory submissions, recruitment and data queries, and travel nationwide. Hybrid or home-based work is available in Paris, Lyon, Marseille.

Qualifications

• Bachelor's Degree in scientific discipline or healthcare preferred; equivalent experience acceptable.
• 2 years clinical oncology experience mandatory.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Excellent written and verbal English communication.
• Ability to travel nationwide and work in hybrid/home-based settings in France.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close out) per scope and GCP/ICH.
• Administer protocol and study training to sites and maintain regular communication.
• Ensure quality and integrity of site practices and manage regulatory submissions, recruitment and CRF data tasks.
• Verify TMF and ISF documentation in compliance with GCP/ICH and local regulations.
• Create site visit reports and follow-up letters; collaborate with study team.

Connaissances

Clinical monitoring

Regulatory knowledge

Communication skills

Team collaboration

Time management

Formation

Bachelor's degree in life sciences/healthcare

Equivalent combination of education and experience

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Job Overview

Conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

External Job Description

Job Overview

Conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Essential Functions

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Work with experienced clinical staff.
• Perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
• Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Ensure the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
• May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Prior 2 years clinical oncology experience mandatory.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of applicable protocol requirements as provided in company training.
• Be flexible with the ability to travel nationwide
• Flexible working hours in an hybrid or home-based role in Paris, Lyon, Marseille

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.