Scientia Clinical Research Ltd

Location: Sydney . CBD, Inner West & Eastern SuburbsIndustry: Healthcare & Medical . Clinical/Medical Research 

About Scientia Clinical Research 

Scientia Clinical Research (SCR) is the first publicly funded purpose-built early phase clinical trials centre in NSW. We focus on first into human and first into patient studies across a broad range of therapeutic areas.

Key Accountabilities / Responsibilities:

  • Perform quality data entry of clinical trial data into (e)CRF in compliance with eCRF guidelines ICH GCP and company SOPs.
  • Ensure data is entered and queries answered within the clinical trial agreed timelines. 
  • Participate in monitoring visits where required
  • Assist clinical study coordinators with clinical trials activities and perform these tasks to a high standard as per protocol, ICH GCP and company SOPs.  Complete the tasks according to agreed timelines
  • Flexibility and willingness to work as required to meet timelines (i.e. early hours, after hours, and weekends) as discussed with SCR managers
  • Assist in the preparation of study documentation, worksheets, and other source documents with accuracy and in a timely manner ensuring that contents are current
  • Tracking of CRF pages received and entered, tracking of data queries sent received and entered
  • Quality control data entry activities and work with data entry team to prevent re-occurring data entry errors
  • Assistance with meeting data entry timelines, including requesting additional support when required
  • Assist with aspects of participants stay at Clinical trial unit as required
  • Other tasks and responsibilities as discussed with the Line Manager when necessary

Skills, Knowledge and Experience

  • Graduate in a clinical or life sciences related field
  • Relevant experience/qualifications in allied professions may also be considered
  • Data entry of clinical trial data using Clinical Data Management software
  • Experience with Medrio and/or Medidata Rave is desirable 
  • Experience in other EDC/e-CRF systems
  • Understanding of medical terminology
  • Understanding of clinical trial processes 
  • Effective interpersonal and communication skills (written and verbal) and ability to collaborate with a wide range of internal and external stakeholders
  • Ability to work flexibly, autonomously with experience in dealing with time demands, competing priorities, or unexpected events
  • Excellent organisational and time management skills, with proven focus on the quality of work produced

If you would like more information about this opportunity, please contact careers@scientiaclinicalresearch.com.au and quote “Clinical Study Coordinator”. 

Thank you for your interest.