Novotech is seeking a Clinical Research Associate to perform site evaluations, initiation, monitoring, and close-out visits, maintaining documentation according to project-specific guidelines. The role involves supporting subject recruitment, quality control, regulatory submissions, and project start-ups. The company promotes inclusivity and offers flexible working options and development programs.
Requirements
- Performing site evaluation, initiation, monitoring and close-out visits, plus maintaining appropriate documentation according to a project-specific monitoring plan, ICH-GCP, and applicable regulations.
- Supporting the development of a subject recruitment plan.
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites.
- Evaluating the quality and integrity of site practices.
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Assist of country and/or site start up activities, including but not limit to country/site ICF development, preparation of IRB submission package, site contract and budget negotiation, and regulatory documents collection.
- Perform the tasks assigned by line manager.
- Strong organizational and problem-solving skills.
- Excellent written and verbal communication skills in English.
- Good computer literacy e.g., MS word, Excel, PowerPoint, internet.
Benefits
- Flexible working options
- Paid parental leave
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
