Description
We are seeking a Clinical Research Coordinator to join our team.
The successful candidate will be responsible for:
- Setting up and maintaining the site level Trial Master File (TMF)/electronic Trial Master File (eTMF), coordinating document collection, uploading into SharePoint/eTMF, checking document completeness, and providing TMF/eTMF quality control (QC) if required
- Coordinating on Ethics Committee (EC) submission dossier, site start-up preparation, and EC fee application and tracking
- Processing protocol amendments, which may include Informed Consent Form (ICF) updates
- Collecting and updating study trackers/metrics reports for site level if needed
- Assisting in contract signature process; assisting in site level payment initiative and payment and invoice tracking
- Distributing site materials and equipment, documenting printing, shipment, and other administrative work
- Providing business and department office administration support if required
- Undertaking other reasonably related duties as may be assigned from time to time, as appropriate for level of experience
Requirements:
- Bachelor's degree in Pharmaceutical or related field
- Minimum 0.5 years of clinical trial experience in the pharmaceutical or CRO industry
- Basic knowledge of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Broad knowledge of applicable protocol requirements as provided in company training
- Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint
- Good written and verbal communication skills, including good command of English language
- Excellent organisational skills and ability to prioritise and multitask