CLINICAL RESEARCH ASSOCIATE HF

Job description

Enterprise:
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference in patients’ daily life, wherever they live and enable them to enjoy a healthier life.
Program SaVIE (VIE of Sanofi) is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since the VIE Program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered.
We are looking for a candidate for a VIE mission of:
Clinical Research Associate
- VIE Contract (W/M)
Job Role
The incumbent will typically be responsible for managing 10
- 20 investigational sites at any given time, depending upon the nature and complexity of the study.
To achieve success it is critical that the CRA:
- Ensures that the clinical study is conducted in accordance with company SOPs, GCP guidelines and other regulations in force.
- Establishes excellent working relationships with external personnel directly involved in study conduct and maintains these despite the difficulties that often arise during the course of a clinical study.
- Works with the personnel at the sites to ensure patients are recruited and managed both safely and effectively in order to meet the study targets.
?
Develops and maintains knowledge of many areas of science and medicine in order to facilitate study conduct, understand patient management and ensure adequate reporting.
KEY RESULTS/ACCOUNTABILITIES
1. At study start-up
- Performs/participates in study site selection visits in the investigational sites.
- Assists the CPAs (Clinical Project Leader) in the preparation/collection of Essential Documents required for timely study set-up
- Facilitates negotiation of site Clinical Trial Agreements (CTA) prepared by the Clinical Project leader (CPL) or Start-Up CRA.
- Ensures that sites apply for and receive hospital/practice/institution approval (e.g. R&D).
2. Throughout the study
- Assists the CPL/CPA in maintaining the local study files, ensuring completeness of the country-level and centre-specific files .
- Ensures accurate assessment of study site recruitment target and subsequent delivery to target.
- Ensures quality of clinical study data at study site, conducting site personnel training
- Performs monitoring visits in the investigational sites and ensures monitoring follow up.
- Provides timely written documentation of all visits/contacts in appropriate reports.
- Performs post-study monitoring visits to close investigational sites.
3. Safety throughout the study
- Monitors the timelines of SAE transmission from the investigators and makes sure reminders are sent to investigators, if delayed.
- Regularly trains investigators in SAE reporting requirements and safety information filing requirements / process in clinical studies.
- Monitors the presence safety information and updates in the ISF.
4. Training and Quality
- Participates in all required internal & external education and training.
- Complies with relevant global and local SOPs in all activities.
- Prepares for and follows up CSU and investigational site audits and inspections.
5. Ethical Leadership
- Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role
6. Environmental and Safety Leadership
- To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
- Master Degree in Nursing , Life Science or similar
- Knowledge of and experience with Good Practices and other regulations in force; ability to learn and apply SOPs
- Well organized, with good time management and prioritizing skills
- Good communicator, accurate, autonomous
- Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting
- Good verbal and written English essential