We are currently looking to strengthen our Clinical Monitoring team in Bremen and are seeking experienced CRAs (at least 1-year experience in Clinical Monitoring activities). At the moment, we are especially searching for CRAs that will be dedicated to one sponsor exclusively.
In this international business, you need to speak and write German and English fluently. A third language is appreciated. Our Clinical Research Associates provide clinical research study support according to Standard Operating Procedures (SOPs) of GCP-Service or Sponsor, ICH/GCP Guidelines and the national laws and regulations.

Depending on the experience level the CRAs can work from home after the initial training in our office. You can expect up to 50% travel work time throughout Europe. The salary will depend on your performance. This gives us the chance to pay good people better compared to our competitors.
Our pension plan is above the average and you can expect some additional advantages like a notebook, mobile phone and company car.

Core responsibilities:

• Completing project activities associated with monitoring functions of clinical research studies (Medicinal products and Medical Devices)
• Performing monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
• Submission of clinical trial applications to Ethic Committees and Competent Authorities – depending on sponsor dedication.
• Lead a group of CRAs as Lead-CRA (depending on experience level and leadership skills)

Qualifications needed:

• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience.
• Understanding of SOPs, WIs, local regulations as well as ICH-GCP guidelines.
• Demonstrates ability to prioritize and manage time for the preparation, completion and follow up of monitoring tasks.
• On-site experience with most types of visits; PSV, SIV, IMV, RMV, COV.

Interested? Please send us your electronic application (incl. salary expectations and earliest start date) and your CV to:

Marco Schwarzer
GCP-Service International Ltd. & Co.KG
Anne-Conway-Str. 2
28359 Bremen
Germany
Phone: +49 (0) 421 89676642
Fax: +49 (0) 421 16697546
E-mail: mschwarzer@gcp-service.com