Train to become a Clinical Trial Associate through assistance in delegated tasks to sup- port the clinical trial team in the conduct of clinical trials within Translational medicine and ensuring that all essential documentation is collected, maintained and filed during the study.
Major Accountabilities (Describe the 5 or more main results of the role to be achieved )
1. Provide support to the Clinical Scientist (CS) with many of the tasks involved with the smooth running of clinical trials in compliance with *** processes. Collaborate with the CS in taking action to address issues as they arise.
2. Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary.
3. Interactions with Investigator sites e.g. to collect relevant documentation, provision of study materials/documents
4. Liaise with contract organisations, vendors and other suppliers of project support services to ensure study deliverables are met e.g. contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups.
5. Provide input on agendas, create materials, liaise with meeting planners and coordinate logistics for key meetings e.g. internal CS meetings or external investigator meetings. May attend and present at these meetings as appropriate.
6. Help ensure accuracy of clinical trial management databases and resource/budget tracking tools, providing information, maintaining meeting minutes and following up on questions as necessary. Help check for discrepancies and take actions to correct as necessary.
7. Identify areas for process or technology improvements with regard to tasks undertaken within the role.
8. Assist in the ordering of clinical trial supplies
9. Assist in the compilation of the clinical study report and its appendices.
10. In collaboration with the Trial Document Specialist responsible for setting up and maintaining Trial Master Files as assigned and ensuring all relevant study documents are filed and archived based on the appropriate guidelines.
11. Audit existing Paper Trial Master Files, collect outstanding documents and archive after study is completed.
12. Assist the CS in organizing Investigator/Site Initiation Meetings and/or First Dose/Monitoring Visits.
1. Previous experience in clinical trials (e.g. clinical
trial design, execution and operations) is preferred but not required
2. Good organizational and interpersonal skills.
3. Ability to work in a team as well as independently if required and to manage multiple priorities with support.
4. Computer literate.
Source: Job Diva – Job Listing