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 is a work-from-home, remote based position from any US geography.
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
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
