Clinical Research Associate
il y a 2 semaines
Located in Paris at the heart of Europe’s largest hospital, the Pitié-Salpêtrière, the Institute of Myology was created in 1996 under the impetus of an association of patients and parents of patients, the AFM-Telethon. Its objective is to promote the existence, recognition and development of myology as a clinical and scientific discipline in its own right. The Institute of Myology coordinates medical care, fundamental research, applied research, clinical research and teaching around the patient. In the future, the creation of the Myology Foundation will allow the Institute of Myology’s actions to be perpetuated and expanded.
**Context and Purpose**
Clinical studies are at the heart of the activity of the Institute of Myology, which includes two clinical trial platforms for neuromuscular diseases, I-Motion pediatric (located on the site of the Trousseau Hospital) and I-Motion adult (located on the site of the Pitié Salpêtrière Hospital).
The Institute of Myology Association is recruiting a Clinical Research Associate (CRA) to ensure the implementation and monitoring of clinical trials in close collaboration with the medical and paramedical staff.
**Main tasks**
Under the supervision of your N+1, in collaboration with the investigators and the various academic and industrial stakeholders, you will be responsible for setting up and monitoring adult and paediatric clinical trials, guaranteeing the quality of the data collected and compliance with the regulations.
Your main responsibilities will include
- Collecting and writing the documents required to ensure technical compliance (study leaflets, worksheets, procedures) and regulatory compliance of clinical trials.
- Ensuring the operation of the logistics required for the conduct of clinical trials (patient and stakeholder planning, monitoring of samples and treatment units if applicable, etc.).
- To control the progress of the trials in accordance with the texts in force, good clinical practice and standard operating procedures.
- Suggest improvements and adaptations to operating procedures if necessary.
- Verify and guarantee the quality of data, and organise site visits and working meetings with internal and external contacts (set-up visits, monitoring, closure, internal team meetings, etc.).
- Possible travel on a national or international scale.
- Regular activity reports with the project team.
**Profile required**
- 4 years of higher education plus training as a clinical research associate.
- Experience in the field of clinical research in an equivalent position desirable
- Good interpersonal skills
- Good command of the English language
- Good command of the Pack Office and databases.
Nature of the position: 12-month full-time contract (35 hours)
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