Located in Paris in the heart of the largest European hospital, the Pitié-Salpêtrière, the Institute of Myology was created in 1996 by AFM-Téléthon, a patient’s organization. Its objective is to promote the recognition and development of myology as a standalone clinical and scientific discipline. The Institute of Myology coordinates, around the patient, medical care, basic research, applied research, clinical research and teaching. The Institute of Myology Association, an association under the law of 1901, was created in 2005 by the AFM-Téléthon as a support structure for this group.
The I-Motion Adults platform, located within the Institute of Myology and created in July 2019, is a clinical research platform dedicated to the implementation and conduct of clinical trials on neuromuscular diseases affecting adult patients. Located in the Pitié-Salpêtrière Hospital, the platform works in close collaboration with the service of Neuro-Myology, the Hospital’s Reference Center for Rare Neuromuscular Diseases and the I-Motion Pediatric platform at the Trousseau Hospital. There is also constant interaction with the research teams of the Myology Centre for Research as well as with the various entities within the AFM-Téléthon galaxy (Généthon…).
Under the supervision of the N+1, Head Physician of the I-Motion Adults Department:
- Coordinate one or more clinical trials and carry out the medical follow-up of patients included in these trials.
- Participate in the construction of a reference department in its modalities of shared Good Practices and common tools with other centers.
- Organize the management of the databases, including the piloting of participants such as the CRAs, partners and scientific experts.
- Ensure synergy with historical partners, including with the “Strike Force” of the AFM-Téléthon, in particular with Généthon.
- Play a key role in the conduct of the centre’s portfolio of clinical research including enzyme and gene therapy trials, acting as sub-investigator to deliver GCP compliant clinical trials and natural history studies in patients with neuromuscular diseases run in the I-Motion Adults platform. You will have the opportunity to learn about clinical trial design, outcome measures, regulatory requirements and ethical issues in conducting clinical research in rare diseases and to develop knowledge and competence to conduct GCP compliant clinical research.
- Identify, include and carry out the medical follow-up of patients in the framework of clinical trials by ensuring compliance with the protocols and regulations in force and with good clinical practices. In this context, an AP-HP shift will be set up in the Neuromyology department.
- Collaborate with the principal investigator, the CRO and the study sponsor.
- Coordinate between the various stakeholders: physicians, pharmacists, health care teams, assigned project team (CRA, CP) and laboratories participating in the protocols.
- Oversee the planning and organization of each patient’s visit.
- Write research reports and activity reports.
- Prepare and participate in clinical trial selection, set-up, monitoring, close-out and audit visits as required.
- Participate in team meetings and in the management of the platform’s quality assurance system.
- Be a scientific force for the development of new clinical research projects on neuromuscular diseases : publish and present high level scientific information including writing and presenting reports relevant to the work being carried out as part of clinical research as well as support the submission research proposals to funders where appropriate
- Have a regular liaison with the Principal Investigators (PIs) and senior members of the research teams to discuss the ongoing research and next possible steps
- Support the clinical initiatives of the Neuromuscular Team, including internal and audits and meetings
- Supervise the good practices of database management for which AIM is a promoter and/or partner with private institutional contacts and scientific experts; internally, in reference with the business contacts: quality, legal (including RGPD), development, digital.
- Holder of a valid medical degree in France, and registered with the Order Council.
- Medical expertise in a clinical field related to the activities of the I-Motion Adults platform:
Neurology, Neuromyology, Clinical Research.
- Good Clinical Practice Training supplemented by at least 1 year of experience in clinical
- Experience in database management standards is a plus.
- Fluent and operational English
- Excellent writing and communication skills adapted to the target (internal and external: health authorities, health professionals, patients)
- Interpret and use scientific information in a synthetic manner
- Good communication and interpersonal skills
- Knowledge of the regulatory aspects of clinical research would be a plus.
- Ability to prevent and/or mediate conflicts and tensions
- Be diplomatic and ethical in teamwork
This position is to be filled on a full-time permanent contract and is based at the Institute of Myology (Hôpital Pitié-Salpêtrière, Paris 13)
Please send your application (CV + cover letter) by e-mail to the following address: firstname.lastname@example.org