Scientia Clinical Research Ltd
Location: Sydney . CBD, Inner West & Eastern SuburbsIndustry: Healthcare & Medical . Clinical/Medical Research
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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 firstname.lastname@example.org and quote “Clinical Study Coordinator”.
Thank you for your interest.