AIXIAL 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 HQs are located in Paris area, France, with offices all across Europe.
We are currently looking for a Senior CRA with at least 3-5 years of experience in monitoring.
Ensure 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.
Support 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.
1st study in Phase III drug, pain. International (4 countries + Italy):
- 5 centers in Italy
- submissions done in Italy, wait for amendment
- Need to do initiation visit
2nd study, from the beginning, Phase III drug, pneumology :
- many centers will work with them
- the Clinical project manager is in Belgium and he has sent the feasibility questions to the centers
- so the CRA has to do the monitoring visits and following the regulatory submissions with the italian authorities
- 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.
- Efficiently manage the planning with the site in order to ensure an adequate rate of monitoring and/or sites contacts, as per applicable procedures and plans.
- Working in synergy with the rest of the AIXIAL Project Team. Being a proactive interface between the Project Team and the investigator’s team.
- Identify any issue or blocking point to the study running on the site.
- Ensure transparency in the escalation of information to the Project Team.
- Developing and maintaining an adequate level of knowledge on the monitoring and project related activities and, if needed, request adequate trainings to the management.
- Follow the training proposed by the Project Team or by the AIXIAL management.
- Ensuring good communication with the Project and Investigator’s teams.
- Prior to communicate, ensuring that information is true and can be verified.
- Updating regularly Project Dashboards related to monitor’s activities.
- 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.
- Ensuring that Clinical Studies are performed in accordance with the GCPs, Pharmacovigilance requirements and applicable regulations. Alerting the Lead CRA oor COPM of any deviation or finding detected on site.
- Informing permanently about applicable regulations in the clinical research area.
- Participating to the development of Project dashboards for tracking and reporting related to monitor’s activities.
- Proposing in a proactive manner any improvement that may have a positive impact on the Clinical Research conduct at AIXIAL on for the Project.
- Participating to the preparation of study documents and tools and proposing improvement ways (investigators lists, study logistics, data management activities, other…)
Qualities and skills :
- At least 3-5 years of successful experience as a CRA in a CRO or Pharmaceutical company
- Master's degree and/or Diploma of Clinical Research Associate
- Ability to identify and stratify priorities
- Proven communication skills
- Willingness to Team working and ability to escalate information on time, according to the level of importance.
- Solution-oriented mind-set
- Sense of synthesis
- Organisation skills
- Respect of procedures
- Knowledge of the applicable Regulations in your activities field (Cf. List-REG-001)
- Driving License
Computer Skills :
- Office software: Word, Excel, PowerPoint, Adobe Acrobat Professional
- CRF/RDC tools
- CTMS tools
- Italian and english
- French is a plus