The Regional Study Coordinator (RSC) is responsible for the successful delivery of all operations of a clinical study in their specific area of the world. The RSC acts as the appointed Liaison between Global Project Management, Client Representatives and other CCLS departments involved in the clinical study to ensure the successful management of regional study responsibilities. The Regional Study Coordinator may communication with the Client when a task is being delegated by the Global Study Manager. Regular communication is essential with the appointed Global Study Manager who is accountable for the entire protocol. This position must be in compliance with the CCLS Global Project Management strategy and deliver outstanding customer satisfaction and performance.
1. Act as regional liaison between Global Study Manager and various CCLS departments involved in the study
2. Act as regional liaison between assigned Client representatives (eg. CRA, Site Monitors) and the corresponding local CCLS platform; occasionally, the Regional Study Coordinator can represent Global Study Manager in interactions with the main client contact
3. Close collaboration with the Global Study Manager for all study related aspects that are pertaining to the corresponding local platform and through all study stages, from set-up to closure
4. Review the study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design Lead
5. Ensure a detailed knowledge of the SOW specifications and very good understanding of how the SOW specifications impact every operational aspect of the clinical trial
6. Manage day-to-day local study related activities, especially logistics, monitoring and study supplies, keeping the Global Study Manager informed of any study development
7. Monitor, track and provide resolution to all local study issues, keeping the Global Study Manager in the communication loop
8. Responsible for implementing monitoring and setting up of local performance metrics and taking corrective actions when needed.
9. Liaise with the Global Study Manager for any tasks assigned to the Regional Study Coordinator as part of the Global Monitoring Plan
10. Demonstrate ability to work in a matrix environment where task assignments can be channeled down to be completed by Regional Study Coordinators while other task assignments will need to be delegated to other functional groups; demonstrate flexibility in handling both categories of tasks
11. Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date
12. Comply with CCLS Global Project Management strategy
13. Support a culture of continuous improvement, quality and productivity
14. Other duties as assigned
- Degree in scientific background
- In lieu of above educational background, related working experienced in CRO or clinical research industry is required
- Ability to use computer and office software applications (e.g. Microsoft Word, Excel, MS-Access and Outlook)
- Strong interpersonal skills
- Proficiency in a second language like Chinese, Korean or Japanese will be an added advantage
- Influence and negotiation skills
- An eye for the details
- Preferred 1 year experience in CRO or related clinical research/ drug development industries
Preferred 2 years customer service experience, preferable in pharmaceutical industry (Education may be substituted for experience)
- Demonstrated ability to plan and prioritize.
- Demonstrated communication and organizational skills.
- Demonstrated attention to detail.
- Proven ability to excel in a fast paced environment
- Proven teamwork
- Proven experience and knowledge of processes and tools used in department
- Demonstrated ability to liaise with internal departments
- Demonstrated ability to facilitate meetings
- Demonstrated participation in process improvement initiatives
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