Clinical Research Associate (CRA)
Secteur : Prestataire (CRO, VM, communication santé, …) Famille de fonction : Développement cliniquenbelhachemi@scope-international.com
Description du poste et des missions
SCOPE International is an independent Full-Service Contract Research Organization (CRO) with a network of 15 local offices and business entities throughout Europe and USA. SCOPE offers a complete range of clinical development and consulting services to the pharmaceutical, biotechnology and medical device industries, and is supported by long established partnerships in other geographies.
Scope International France has an exciting opportunity for a Clinical Research Associate (CRA) with 1 ½ -2 years on-site monitoring experience to take the next step in their career and join our growing FR team.
Job Description
As a Clinical Research Associate (CRA) at SCOPE, you will have a key role in the success of clinical trials. You will be the primary contact and support for trial sites, ensuring that the study is conducted according to the protocol, ICH-GCP, regulatory requirements and standard operating procedures (SOPs). If interested, please send your resume to nbelhachemi@scope-international.com
Profil souhaité
You will:
- Preparation and submit the regulatory files.
- Perform clinical trial site evaluation, initiation, routine monitoring and close out visits.
- Review and ensure Investigator Site Files (ISFs) are up to date and collect essential documents for the Trial Master File (TMF)
- Ensure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical trial supplies.
- Update all relevant tracking systems on an ongoing basis.
- Prepare and submit trip reports according to project timelines.
- Oversee and support sites with subject recruitment and retention strategies.
- Interact directly with sites, including clinical investigators and other health care professionals involved in the clinical trial to maintain a positive rapport and ensure project expectations are met.
Compétences requises
Qualifications & Requirements:
- A Master or higher graduate degree within a science related field, with a CRA training.
- 1-2 years of on-site monitoring experience required.
- Ability and willingness to travel up to 80%, depending on project needs.
- Competent in written and oral English and French (German would be one more)
- Excellent organization and communication skills.
- Ability to prioritize multiple tasks and achieve project timelines.
- Ability to take initiative and work autonomously.
- Computer skills (Microsoft Office).