CTA Freelancer - 3 months contract - based in Neu-Isenburg

PURPOSE

Provide administrative support to clinical projects under direction of line manager, Clinical Research Specialist and/or other designated clinical team members. Assists with general administrative functions as required.

RESPONSIBILITIES

  • Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
  • Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness.
  • Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Knowledge of applicable protocol requirements as provided in company training
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
  • Good written and verbal communication skills including good command of German and English language
  • Effective time management and organizational skills
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

High or Secondary School diploma/certificate or country’s educational equivalent and 3 years administrative support experience; or equivalent combination of education, training and experience


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