Description
We are seeking a Clinical Research Assistant to support our clinical research team. As a Clinical Research Assistant, you will play a crucial role in ensuring the smooth operation of clinical trials.
Responsibilities:
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems, such as Trial Master File (TMF)
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to standard operating procedures
- Review study files for completeness
- Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of 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:
- Bachelor's degree and above
- 1-3 years of administrative support experience
- 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 good command of 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 Harmonisation (ICH) guidelines
- Knowledge of applicable protocol requirements