Senior Clinical Research Associate (SCRA) (m/f/d)

Company: GCP-Service International 

Location: Home-based in France 

Employment type: Full-time 

Experience level: 5 years+ 

Languages: French and English 

We are expanding our team in France and are looking for an enthusiastic Senior Clinical Research Associate! 

GCP-Service International is a mid-size and privately owned independent full-service Contract Research Organization (CRO) founded in 2004 with headquarters in Bremen, Germany. Our satellite offices include locations in Siegburg (Germany), Prague (Czech Republic), Nijmegen (Netherlands), Gdynia (Poland) and Singapore (The Republic of Singapore). We conduct a wide range of clinical studies across the pharmaceutical, medical device, and in vitro diagnostic medical device industries worldwide.

In this international business, you need to speak and write French and English fluently. You should expect to spend up to 60% of your working time travelling throughout Europe. While the primary focus will be on sites in France, assignments may also include sites in French-speaking Belgium and Switzerland, as well as other countries such as the United Kingdom and Ireland. 

Core responsibilities: 

• Conduct qualification, initiation, monitoring and close-out visits at assigned investigative sites (either on site or remotely) in accordance with study protocols, Standard Operating Procedures (SOPs), ICH GCP Guidelines, and all applicable regulatory requirements. 

• 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. 

• At last 5 years of on-site experience (qualification, initiation, monitoring and close out visits). 

• Strong knowledge of national and international clinical research regulatory requirements (e.g., ICH-GCP, ISO 14155). 

• Relevant soft skills: strong work ethic, positive attitude, effective oral and written communication, attention to detail, adaptability, and the ability to manage multiple priorities efficiently. 

• Fluency in spoken and written French and English. 

 What GCP-Service International offers: 

• A business driven by core values: respect, trust, flexibility, reliability, growth, fairness and honesty. 

• An independent, diverse and interesting area of responsibilities. 

• An excellent working environment with flexible hours. 

• A young and innovative corporate culture and management, with a clear path to personal and professional development. 

• A competitive salary based on your experience.