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

at  GCPService International

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) with headquarters in Bremen, Germany. Our satellite offices include locations in Berlin and Siegburg (Germany), Prague (Czech Republic), Nijmegen (Netherlands), Gdynia (Poland) and Bratislava (Slovakia). 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 (in addition to sites in France, there is a possibility of having sites in French-speaking Belgium and Switzerland).

• Location: Home-based in France
• Employment type: Full-time
• Experience level: 4 years+ including experience in Haematology-Oncology
• Languages: French and English

QUALIFICATIONS NEEDED:

• Bachelor’s degree or higher in life sciences/healthcare or nursing degree or equivalent combined education and experience.
• At last 4 years of on-site experience (qualification, initiation, monitoring and close out visits) including experience in Haematology-Oncology.
• 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.

• 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.