Experienced Clinical Research Associate, Multi-Sponsor, France

IQVIA; Paris; Hybride; EUR 55 000 - 75 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Monitoring Specialist to perform site visits, ensure protocol adherence and maintain high data quality in line with GCP/ICH. The role supports project execution through regular communication with sites and meticulous documentation.

Requirements include a Bachelor's degree in science or health care, at least 2 years in oncology monitoring, and proficiency with Word, Excel and PowerPoint. Hybrid/home-based in Paris, Lyon or Marseille with nationwide travel.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted.
• Prior 2 years oncology clinical monitoring experience mandatory.
• Proficient in Microsoft Word, Excel and PowerPoint; use of laptops and mobile devices.
• Strong written and spoken English communication; able to travel nationwide.

Responsabilités

• Conduct site monitoring visits (selection, initiation, monitoring and close out) per SOPs and GCP/ICH.
• Administer protocol training to sites and maintain regular communication.
• Ensure quality and integrity of study site practices and document management.
• Track regulatory submissions, recruitment, CRF completion, data queries and resolutions.
• Prepare visit reports, follow-up letters and site management documentation.
• Collaborate with study team members to support project execution.
• Travel nationwide and work in hybrid or home-based settings in Paris, Lyon, Marseille.

Connaissances

Communication

Organizational skills

Time management

Problem solving

Formation

Bachelor's Degree in science or health care

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

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.