CTA duties:
- 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
- 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
IP Technician duties:
Assist in dispensing and/or compounding Investigational Products (IP) for clinical studies as per study protocol and other applicable documents.
• Assist in areas of study specific IP Management, where trained & delegated, such as IP orders, receipt, sponsor communication and study archiving.
• Assist in areas of study set-up where trained or qualified
• Review sections of pharmacy manuals, worksheets, prescriptions
• Proactively communicate and participate in collaborations with team members from other SCR departments in study and non-study related matters.
• Apply correct compounding techniques, whether aseptic or non-sterile, to IP manufacturing or compounding.
• Assist in maintaining non-study specific stock inventory including storing and handling according to applicable regulations, guidelines and policies.
• Provide training to relevant staff in aseptic techniques,