Description
We are seeking a Clinical Research Assistant to support our team in North Sydney, New South Wales, Australia. This is a full-time role that involves assisting Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams with various tasks.
Essential Functions
- Assist CRAs and RSU teams with updating and maintaining clinical documents and systems, such as Trial Master File (TMF), to track site compliance and performance within project timelines.
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures.
- Conduct periodic reviews of study files for completeness.
- Assist CRAs and RSU teams with preparing, handling, and distributing Clinical Trial Supplies and maintaining tracking information.
- Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications
- High School Diploma or equivalent.
- At least 2 years of administrative support experience in clinical trials.
- Equivalent combination of education, training, and experience.
- Computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills, including a good command of the English language.
- Effective time management and organisational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Awareness of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.