Clinical Research Associate

il y a 3 semaines


Paris, France Cmed Temps plein

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India.

The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.

We are currently looking for an enthusiastic and talented Clinical Research Associate. This position is partially remote and can be based in our Paris or Lyon office. Required to travel.

PURPOSE AND MAIN RESPONSIBILITIES

Purpose
- Ensures that the Monitoring activity of Clinical Studies undertaken by AIXIAL is made in accordance with the protocol, study specific procedures, Good Clinical Practices rules (GCP), Pharmacovigilance requirements and applicable laws
- Supports the team in the development procedures, templates and documents related to the company and to each project by adopting a constructive behaviour and sharing experience or suggestions

**Responsibilities**:
1. Taking the responsibility of monitoring activity for study investigative sites that have been assigned. This includes ensuring that all data collected by the site is consistent with the actual data filed and monitored on site, that technical and human resources are put in place and operational, that patients’ files are available and well documented, that information reported by the site is correct and true, that the site follows the GCPs

2. Efficiently manages the planning with the site in order to ensure an adequate rate of monitoring and/or sites contacts, as per applicable procedures and plans

3. Working in synergy with the rest of the AIXIAL Project Team. Being a proactive interface between the Project Team and the investigator’s team

4. Identifies any issue or blocking point to the study running on the site

5. Ensures transparency in the escalation of information to the Project Team

6. Developing and maintaining an adequate level of knowledge on the monitoring and project related activities and, if needed, request adequate trainings to the management

7. Follows the training propose by the Project Team or by the AIXIAL management
8. Ensuring good communication with the Project and Investigator’s teams

9. Prior to communicate, ensuring that information is true and can be verified

10. Updating regularly Project Dashboards related to monitor’s activities

11. Ensuring an adequate level of service to the client as per commitments taken by the COPM

12. Alerting the Monitoring Lead or the COPM about any deviation or finding that may have a negative impact for the Project, AIXIAL or for the client

13. Ensuring that Clinical Studies are performed in accordance with the GCPs, Pharmacovigilance requirements and applicable regulations. Alerting the Lead CRA or COPM of any deviation or finding detected on site

14. Managing travels planning in order to optimise travel time, distances, fatigue and costs

15. Informing permanently about applicable regulations in the clinical research area

16. Participating to the development of Project dashboards for tracking and reporting related to monitor’s activities

17. Proposing in a proactive manner any improvement that may have a positive impact on the Clinical Research conduct at AIXIAL on for the Project.

18. Participating to the preparation of study documents and tools and proposing improvement ways (investigators lists, study logistics, data management activities, other )

19. Contributing proactively to the development of operational procedures in terms of Clinical Research and follow operational procedure wherever applicable

Qualifications and skills
- At least 1-2 years of successful experience as a CRA in a CRO or Pharmaceutical company
- Diploma of Clinical Research Associate and at least 5 years post-graduate
- Driving License
- Ability to identify and stratify priorities
- Analysis and assessment skills for clinical research related risks
- Writing skills for built and complex mails
- Proven communication skills
- Willingness to Team working and ability to escalate information on time, according to the level of importance.
- Mobility
- Solution-oriented mind-set
- Rigour
- Sense of synthesis
- Organisation skills
- Reactiveness
- Respect of procedures
- Knowledge of the applicable Regulations in your activities field (Cf. List-REG-001)

Computer Skills
- Office software: Word, Excel, PowerPoint, Adobe Acrobat Professional
- CRF/RDC tools
- CTMS tools

Languages
- English: reading, writing and speaking (exp


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