71 days ago on ctcon.ch

Trial Administration Specialist

CTC Clinical Trial Consulting AG

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Trial Administration Specialist

Reference Number: 895130-W
Type of placement: Contract, 12 months
Location: Switzerland, North West

Introduction:

Provide support to the trial team in all phases of the clinical study conduct, including maintaining key information in clinical study systems in accordance with ICH-GCP guidelines, US Food and Drug Administration (US FDA) requirements, and Quality System documents (QS docs). This position closely collaborates with other team members in addition to the Trial Management Team (e.g., Documentation Group, GCO Administrative Support, CRAs, Country Clinical Monitoring Manager (CCMMs).

 

Main Responsibilities:

  • Updates and maintains clinical study systems (e.g., the CTMS)
  • Assists (Global) Trial Manager ([G]TM) with clinical study site payments and invoices processing
  • Prepares site related documents (e.g., Investigator Site Files [ISF])
  • Prepares, handles, distributes, and files clinical study documentation and reports (e.g., site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study Report [CSR])
  • Orders, distributes/ships, and tracks study related non-clinical supplies
  • Works closely with Administrative Support Group for shipments and other routine tasks (e.g., ISF binder preparation)
  • Handles and processes site contracts, including obtaining signatures
  • Requests and handles insurance certificates and policies in cooperation with (G)TM and Group Coordinator
  • Files/uploads documents into systems (e.g., Clinical Trial Portal, contracts management system, eTMF)
  • Maintains and updates site and user contact lists for External Service Providers (ESPs)
  • Performs administrative tasks to support Trial Management team members with clinical study execution (e.g., Schedule meetings, assist with Investigator meetings, prepare agendas, and meeting minutes)
  • Liaises with other departments, groups and agencies (e.g., printing company, legal department, procurement group)
  • May act as a central contact for the trial team for designated project communications, correspondence, and associated documentation
  • Reviews study reports (e.g., eTMF reports, Interactive Response Technology [IRT] reports)
  • Performs quality checks (QC) of the (e)TMF or other study documents
  • Assists (G)TM with selected tasks in the ESP management
  • Assists at Investigation meetings
  • Reviews study-related reports and discusses necessary actions with the (G)TM
  • Performs quality checks and review of the TMF in accordance with QS docs
  • Audits and resolve issues of redundancy, currency, and consistency of documents on shared drives and portal
  • Performs other duties as assigned

 

Qualifications and Experience:

  • Bachelor’s degree required (in science related discipline preferred) or equivalent education/degree in life sciences or healthcare; relevant experience may be substituted for degree
  • 2+ years’ experience in a clinical research related position
  • Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint)
  • Knowledge of International Council for Harmonization - Good Clinical Practice (ICH-GCP) guidelines
  • Strong English written and verbal skills
  • Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
  • Working knowledge of electronic Trial Master File (eTMF), clinical trial portals (CTPs) and clinical trial management systems (CTMSs)
  • Some overnight travel (<10%) may be required
  • Ability to find effective solutions when faced with difficult situations and to implement team decisions
  • Relevant working/residency permit or Swiss/EU-Citizenship required