Position:
Clinical Trial Co-Ordinator
Location:
Annacotty, Limerick

Serosep Limited are currently recruiting a Clinical Trial Co-Ordinator for a full time, permanent position here in Annacotty, Limerick.

Reporting to the Product Development Supervisor

As a Clinical Trial Coordinator you will be responsible for leading the development, execution, completion, and reporting of clinical trial(s) according to the regulations, on one or more trials in all relevant aspects of trial preparation, trial conduct, documentation and archiving. The Clinical Trial Coordinator will be the clinical representative within the overall project team.

Main Duties:

  • Work closely with the device project team and provide input to the overall project from a Clinical perspective
  • Lead all aspects of and contributing to the development of study specific documentation e.g. CPSP andCPSRs, ethical approval, case report forms (CRF), data management plan, monitoring plan, project specific training plan, data review plan, statistical analysis plan, etc
  • Supervise set-up and maintenance of study
  • Ensure compliance with the protocol, country regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures
  • Manage the study in line with required timelines
  • Lead risk assessment and identify risk mitigation strategies at the study level
  • Manage feasibility assessment to select relevant regions and countries for the study
  • Conduct site evaluation and selection
  • Lead investigator meeting preparation and execution
  • Monitor progress for site activation and act on any deviations from the CPSP
  • Supervise monitoring of the study and attend monitoring visits as required
  • Raise issues related to study conduct, quality, timelines with relevant managers
  • Ensure data quality including regular review of data and protocol deviations
  • Supervise study close-out activities and contribute to clinical study report writing and review

 

Essential Criteria:

  • MSc in Microbiology/Molecular science or related field
  • Project Management experience
  • Experience working in a regulated environment
  • Strong communication skills
  • Excellent organisation and interpersonal skills
  • Ability to manage multiple priorities
  • Ability to work independently, prioritise and work within a team environment

 

Desirable Criteria:

  • PhD in Microbiology/Molecular science or related field
  • Prior experience as trial/study manager

 

Closing date for applications is 7th October, 2022

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