French-speaking Clinical Research Associate (CRA) (m/f/d)

Location: Home-based in France

Employment type: Full-time

Experience level: 1 to 2 years

We are currently looking for an enthusiastic and motivated Clinical Research Associate to join our remote French-speaking team!

GCP-Service International is a mid-size and privately owned independent full-service Contract Research Organization (CRO) with headquarters in Bremen, Germany. Our satellite offices include locations in Berlin, Potsdam and Siegburg (Germany), Vianen (Netherlands), Gdynia (Poland) and Prague (Czech Republic). We conduct a wide range of clinical studies in both the pharmaceutical and medical device industries across the globe.

In this international business, you need to speak and write French and English fluently.

You can expect up to 60% travel work time throughout Europe (possibility of having sites located in France as well as in the French-speaking Belgium and Switzerland).

Core responsibilities:

  • Conduct qualification, initiation, monitoring and close-out visits at assigned investigative sites (either on site or remotely) in accordance with the study protocol, study monitoring plan, Standard Operating Procedures (SOPs) of GCP-Service International or Sponsor, ICH/GCP Guidelines and the national laws and regulations.
  • Ensure that all relevant documentation for assigned investigative sites is complete and accurate as well as promptly and correctly filed in the Trial Master File.
  • Communicate regularly and effectively with the assigned investigative sites, provide training if necessary.
  • Report site visits, maintain appropriate site status tracking and ensure that the Project Manager and other relevant staff are kept informed of progress and/or problems with the investigative sites.
  • Support the submission of clinical study applications to Ethic Committees and Competent Authorities.

Qualifications needed:

  • Bachelor’s degree or higher in life sciences/healthcare or nursing degree or equivalent combined education and experience.
  • 1 to 2 years of on-site experience in most types of visits (qualification, initiation, monitoring and close out).
  • Good knowledge of national and international clinical research regulatory requirements (e.g., ICH-GCP, ISO 14155).
  • Relevant soft skills: strong work ethic and positive attitude, effective oral and written communication, attention to detail, adaptability, time management and prioritization.
  • Fluency in French and English.

What GCP-Service International offers:

  • An international and flexible working environment.
  • A business driven by core values.
  • A supportive and friendly atmosphere.
  • A competitive salary based on your experience.
  • A room for growth.

Interested in joining GCP-Service International? Please email your application (CV in English, salary expectations and earliest start date) to the below mentioned contact. Do not hesitate to reach out for any questions related to the offer.

Ms. Amandine Guilmandie
Regional Operations Manager
GCP-Service International West GmbH
Siegfeldstr. 11
53721 Siegburg

Phone: +49 162 423 9006