Description
We are seeking a Clinical Research Coordinator to review and implement study-specific plans, support system compliance, and file task-related documentation in the Electronic Trial Master File (eTMF).
Responsibilities:
- Review and implement study-specific plans that describe required expectations for assigned tasks
- Support system compliance and system data entry
- File required task-related documentation in the eTMF
- Review initial/amended Country/Site ICFs for compliance with Sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines
- Liaise with local teams, Start-up Project Managers, and Sponsors to ensure timely approval of Informed Consent Forms
You will also be expected to:
- Complete required trainings according to timelines
- Ensure quality and productivity in day-to-day tasks
- Manage project and technical documentation
- Provide administrative and technical support to internal departments and teams
- Perform checks to ensure quality of work completed
- Escalate issues and resolve them in a timely manner
- Participate in process improvement opportunities
Qualifications:
- University/College degree in life sciences or certification in a related allied health profession
- 3-5 years of work experience in clinical research
- Working knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines
Preferred qualifications include:
- Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook)
- Good written and oral communication skills
- Well-developed organisational skills
- Excellent proof-reading skills
This role is based in a general office environment.