Clinical Research Associate - IQVIA BIOTECH (homebased in France)

IQVIA; Paris; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading global provider of clinical research services is seeking a Sr. Clinical Research Associate to join their dynamic team. This role involves monitoring clinical trial sites, ensuring compliance with regulatory standards, and collaborating with study teams to enhance project outcomes. Ideal candidates will have a background in life sciences and prior monitoring experience, particularly in oncology. Join a vibrant environment where you can make a significant impact on patient outcomes.

Qualifications

• At least 1 year of monitoring experience during site visits, preferably in oncology.
• Completion of CRA training or prior monitoring experience required.

Responsabilités

• Perform site monitoring visits in accordance with GCP and ICH guidelines.
• Evaluate the quality and integrity of study site practices.
• Manage the progress of assigned studies by tracking regulatory submissions.

Connaissances

Communication

Organizational Skills

Problem Solving

Time Management

Financial Management

Formation

Bachelor's degree in a scientific or healthcare discipline

Background in Life Science, Nursing, Pharmacy, or a medical degree

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

Due to our continued growth, we are recruiting for a Sr. Clinical Research Associate to join our team.

This is a great opportunity for a CRA to join a progressive and developing CRO.

IQVIA Biotech is a unique division specializing in working with smaller biotech and emerging biopharma clients, offering a vibrant, fast-paced working environment.

Responsibilities

1. Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with the contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
2. Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
3. Administer protocol and related study training to assigned sites and establish regular communication to manage ongoing project expectations and issues.
4. Evaluate the quality and integrity of study site practices related to protocol conduct and adherence to applicable regulations. Escalate quality issues as appropriate.
5. Manage the progress of assigned studies by tracking regulatory submissions, approvals, recruitment, CRF completion, data queries, and resolutions. Support start-up phases if applicable.
6. Ensure site documents are available and properly filed in the Trial Master File (TMF) and Investigator's Site File (ISF) in accordance with GCP/ICH and regulatory requirements.
7. Create and maintain documentation on site management, monitoring findings, and action plans, including visit reports and follow-up letters.
8. Collaborate with study team members for project support.
9. If applicable, support the development of site-specific recruitment plans and manage site financials according to trial agreements.

Qualifications

• Background in Life Science, Nursing, Pharmacy, or a medical degree.
• Previous experience as a Study Coordinator.
• At least 1 year of monitoring experience during site visits, preferably in oncology or related therapy areas.
• Bachelor's degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
• Completion of CRA training or prior monitoring experience required by some organizations.
• Knowledge of GCP and ICH guidelines.
• Good therapeutic and protocol knowledge.
• Proficiency in Microsoft Word, Excel, PowerPoint, and familiarity with laptops and mobile devices.
• Strong communication, organizational, and problem-solving skills.
• Effective time and financial management skills.
• Ability to work effectively with colleagues, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We accelerate medical development and improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com.