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Associate Specialist, Clinical Research (m/f/d)

Our Clinical Research team is responsible for clinical studies to demonstrate the safety and efficacy of new drugs, and new indications for products already on the market, in order to obtain regulatory approval. Through the use of state-of-the-art technologies and the application of strict scientific and ethical standards, our clinical studies meet the highest quality requirements.

To strengthen our team at our Schwabenheim location, we are looking for you as a Clinical Research Associate (m/f/d), starting immediately, for a fixed-term period of 2 years and on a full-time basis.

The Clinical Research Associate (CRA) is responsible for doing the on-site monitoring of studies / clinical trials at the site level and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval. Responsible for reviewing adverse event cases with investigators, determining and monitoring time schedules, preparing study documents, and issuing status reports. May assist with design, development, and monitoring of clinical evaluation projects. Trains investigators and site personnel. May contact and recommend qualified investigators to perform studies and initiate clinical trials.

Your tasks:

  • Conducting paper and electronic clinical studies under the supervision of the Clinical Study Team Leaders.
  • Assisting in the planning, organization, and archiving of clinical studies (field and laboratory studies).
  • Labeling investigational products according to Good Manufacturing Practice (GMP).
  • Organizing logistics for selected veterinary investigators or laboratories: study product, control product, labeling, study materials, study documentation, confidentiality agreements, and contracts.
  • Providing comments on the study protocol (e.g., practical feasibility, data collection sheets) and study reports.
  • Assisting in the study registration/approval for selected veterinary investigators with local or federal authorities.
  • Conducting user acceptance tests.
  • In-house monitoring of clinical studies according to Good Clinical Practice, other guidelines, and global/local SOPs; additional monitoring at participating practices in Germany and other European countries.
  • Conducting protocol and data entry training in veterinary practices or laboratories.
  • Performing 100% data review, inventory of study medication, and writing monitoring visit reports.
  • Handling queries after data entry and QA audit of raw data. Being a member of the clinical study team, participating in regular meetings, and collaborating with other Animal Health R&D sites (e.g., Boxmeer, USA).
  • Supporting the group in administrative tasks, such as ordering and invoicing (ARIBA system).

Your profile:

  • Degree in a natural science field or a completed education in a similar area.
  • Teamwork skills, excellent communication abilities, and flexibility.
  • Meticulous, structured, and results-oriented work approach; excellent organizational and planning skills.
  • Very good English language skills.
  • Proficient use of MS Office.
  • Willingness to travel regularly (up to 30%).

Our benefits:

  • Flextime account (37.5 hours/week) and an attractive company pension scheme.
  • Competitive salary package: 13 months' salary + holiday bonus (EUR 1,200 annually) + achievement of target bonuses.
  • 30 days of vacation entitlement.
  • Hybrid work model.
  • Small location with a family-like atmosphere in Schwabenheim.
  • Corporate benefits and free (e-) parking.
  • Good company cafeteria.
  • Internal training and development opportunities.
  • International collaboration.
  • Training on the job.
  • Opportunity to contribute own ideas to process design.
  • Insights into the development of veterinary medicines.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse 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 diverse workplace.

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Associate Specialist, Clinical Research (m/f/d)

55270 Schwabenheim an der Selz

Veröffentlicht am 05.06.2024

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