Job Summary:
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 LCLS 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 LCLS Global Project Management strategy and deliver outstanding customer satisfaction and performance.
Essential Job Duties:
1.Act as regional liaison between Global Study Manager and various LCLS departments involved in the study.
2.Act as regional liaison between assigned Client representatives (eg. CRA, Site Monitors) and the corresponding local LCLS 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 LCLS Global Project Management strategy.
13.Support a culture of continuous improvement, quality and productivity.
14.Other duties as assigned.
The Regional Study Coordinator is expected to interact internally on a regular basis and occasionally with external clients throughout all job duties mentioned above.
Experience:
Minimum Required:
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.
2 years customer service experience, preferable in pharmaceutical industry (Education may be substituted for experience)
Education/Qualifications/Certifications:
Minimum Required:
Bachelor or Master degree in relevant fields
Ability to use computer and office software applications (e.g. Microsoft Word, Excel, MS-Access and Outlook)
Strong interpersonal skills
Strong in English
Influence and negotiation skills