Clinical Project Coordinator

Primary Responsibilities:

• Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team
• Support the implementation and maintenance of studies; assist so that Sponsor and Investigator obligations are met and are in compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice
• Support in document management (creation, review, collection, filing, forwarding) including submission documents, meeting minutes and Trial Master Files, from Pre-study Phase to Study Closure
• Support (field) monitors by (but not limited to) preparing checklists, controlling completion status and timelines, updating relevant tracking sheets
• Create, review, finalize, forward and file meeting minutes for all internal and external study-related meetings.
• Support in Celerion process improvement
• Support in-house in performing site feasibility and site qualification visits in order to select qualified sites
• Support to prepare documents for Site Initiation Visits (SIVs), such as presentation slides
• Support to prepare documents for Monitoring Visits
• Support to prepare documents for Close-out Visits
• Perform content review and quality checks of received documents
• Cooperate with central TMF team to keep Trial Master File (TMF) up-to-date and track filed documents
• Support query resolution in a timely manner
• Support Serious Adverse Event (SAE) reporting according to study specifications
• Support in document/review study status, site enrolment status
• As a member of Celerion’s project teams, perform billable work in accordance with Celerion BCDs, SOPs and PGs, and within the relevant timelines
• Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary
• Participate and demonstrate proactive involvement in project/study meetings, internal project/study meetings, and other activities enhancing project progress
• Participate in audits and inspections, including preparation and follow-up activities
• Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements

Requirements:

• Bachelor’s degree in a biomedical-related field, life sciences or equivalent field
• Excellent oral and written communication skills in English
• High level of organization, multi-tasking, judgement and analytical skills
• Good time management skills to ensure adherence to timelines
• Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements
• Dedication to quality and reliability
• Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research
• Ability to work well independently and as part of a team
• Maintain confidentiality of Subject data and Sponsor/Client information
• Computer literate
• Pay attention to detail, be tactful, and diplomatic
• Responds to client needs and is focused on client satisfaction
• Willingness to learn and gain professional experience