Clinical Research Associate (m/w/d)

We are seeking a Clinical Research Associate (m/w/d) to join our team at our innovative research facility in Schwabenheim (near Mainz). This is a full-time position on a two-year fixed-term contract.

Main responsibilities:

• Conducting paper and electronic clinical studies under the direction of the Clinical Study Team Leader
• Supporting the planning/organization/archiving of clinical studies (field and laboratory studies)
• Labelling of investigational products according to Good Manufacturing Practice (GMP)
• Organization of logistics for the selected trial veterinarians or laboratories: study product, control product, labelling, study material, study documentation, confidentiality agreements and contracts
• Commenting on the study protocol (e.g. practical feasibility, data collection sheets) and the study report
• Participation in the study registration/approval for the selected trial veterinarians to the local or federal authorities
• Conducting User Acceptance Tests In-house monitoring of clinical studies according to Good Clinical Practice, other guidelines and global or local SOPs, additional monitoring in participating practices in Germany and abroad in Europe.
• Conducting protocol training, data entry training in veterinary practices or laboratories
• 100% review of raw data, inventory of study medication, writing of monitoring visit reports.
• Processing queries after data entry and QA audit of raw data
• Member of the clinical study team, participation in regular meetings; regular collaboration with other Animal Health R&D sites (e.g. Boxmeer).
• Supporting the group with administrative tasks, e.g. orders and billing (ARIBA system)

Your profile:

• Scientific degree or completed apprenticeship in a relevant field
• Teamwork skills, excellent communication skills and flexibility in an international environment
• Careful, structured and results-oriented working style, excellent organization and planning skills
• Proficiency in MS Office
• Willingness to travel regularly (up to 30%)
• Very good English and good German skills, ideally another European language

We are proud to be a company that embraces the value of bringing various, talented, and committed people together. The fastest way to breakthrough innovation is when multiple ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and appreciative workplace.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Required Skills:
Adverse Event Report, Clinical Evaluation Reports, Clinical IT, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Investigations Training, Patient Recruitment, Quality Mindset, Regulatory Training

Preferred Skills: