Clinical Project Coordinator (Part-Time)

Celerion

95d

About The Position

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity that will make a difference in the future of healthcare? We are seeking a Clinical Project Coordinator to join our Global Clinical Development team! Do you want to learn more? As a Clinical Project Coordinator you will assist with project management and/or site management by supporting in-house activities for studies or projects managed by Celerion. You will support project initiation, project implementation, milestone tracking, and assist in the production of key project progress reports. The primary role of the Clinical Project Coordinator is to support the responsible Clinical Project Manager or Program Director and their designates in their oversight tasks, such as updating and/or reviewing project information system(s), investigator fees, status updates, regulatory submissions and similar duties. This position is part-time and will work approx. 20 hours/week. This is a work-from-home, remote based position from any US geography.

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

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

What This Job Offers

• Job Type: Part-time
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees