Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Trial Coordinator -- Make an Impact at the Forefront of Innovation
Over the past five years, we have supported the top 50 pharmaceutical companies and more than 750 biotech companies across 2,700 clinical trials in over 100 countries.
As part of our global team, you will provide administrative and technical support to the project team. In this role, you will help maintain audit and regulatory inspection readiness by ensuring that study files are reviewed according to the schedules in organizational SOPs and departmental guidance.
You will also support site activation activities and help develop critical paths to enable timely site activation. As a CRG representative, you may use local knowledge, internal systems, external site lists, and sponsor guidance to develop and review site lists for feasibility activities and contribute local input to site tiering. You may also support onboarding by acting as a buddy and training new team members as needed.
What You’ll Do
- Support day-to-day clinical study activities, including regulatory inspection readiness, under the general supervision of the FSP Manager and in collaboration with Client Management.
- Work with Clinical Operations and Study Managers, study teams, and CROs to support activities defined by the clinical trial operating model.
- Review study documents, including essential document packets, study plans, and informed consent forms.
- Support and provide oversight of risk-based monitoring activities.
- Attend key team meetings and prepare minutes for selected studies.
- Support inspection readiness activities, such as preparing SOP lists and collating inspection storyboards.
- Support clinical trial systems, including CTMS- and TMF-related activities for selected studies.
- Assist with vendor contract administration as needed.
- Support study close-out activities, including financial reconciliation.
- Complete additional ad hoc activities as agreed with your manager(s).
Education and Experience
- Bachelor’s degree preferred.
- At least 1 years of experience supporting global clinical trials as a Clinical Trial Coordinator or Project Coordinator.
- Experience with Regional or gloabl studies is an advantage.
- Experience across multiple therapeutic areas, including oncology, is an advantage.
- Experience with Veeva Vault and hands-on experience with the eTMF lifecycle.
Knowledge, Skills, and Abilities
- Ability to work independently and as part of a team.
- Strong organizational skills and attention to detail, with the ability to manage multiple tasks effectively.
- Ability to analyze project-specific data and systems to ensure accuracy and efficiency.
- Strong customer focus and flexibility to reprioritize work as project timelines change.
- Working knowledge of applicable country regulations, ICH Good Clinical Practice (GCP), and organizational and client SOPs and WPDs relevant to project implementation, execution, and close-out.
- Strong written and spoken English, as well as proficiency in the local language where required.
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint, and the ability to learn clinical trial database systems.
- Ability to successfully complete the organization’s clinical training program.
- Self-motivated, with a positive attitude and strong interpersonal, oral, and written communication skills.
- Sound judgment, decision-making, negotiation, and risk-escalation skills.
- Ability to think independently and follow project work instructions accurately.
Working Conditions and Environment
This role follows a hybrid work arrangement, with remote work and in-office attendance as needed to meet business and team requirements.
