The lead CRA coordinates all aspects of the clinical trial projects in accordance with the company’s interest, regularoty requirements and ICH guidelines.
As part of a project team, he/she will:
- Participate to the writing of all study’s document (synopsis, protocole, CRF, safety report, clinical report…),
- Conduct all types of clinical monitoring visits, e.g. pre-study qualifications, initiations, on site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects.
- Select and supervise study’s suppliers (logistic, data management, statistic…),
- Negotiate study budgets with potential investigators up to contract signature
- Take care of the regulatory submission (health authorities, ethical committee…) before and during the study
- Record the studies in due time in databases (such as clinicaltrials.gov),
- Ensure the quality of the trial master file
- Scientific background with at least 5 years as CRA.
- Experience in pediatrics and/or in the field of nutrition would be appreciated
- Fluent English and French,
- Good communication skills including the ability to obtain information and to convince your interlocutor
- Methodical, Rigorous and proactive, you like to work in an evolutionary environment.