Clinical Monitoring Coordinator

Summary

Join Celerion as a full-time remote Clinical Monitoring Coordinator! This role supports clinical monitoring services by assisting with in-house activities for studies and projects. You will collaborate with the Clinical Monitoring Manager and CRAs, overseeing pre-study deliverables, preparing study documents, and providing training. The position requires strong organizational and communication skills, along with a profound knowledge of Good Clinical Practice and relevant regulations. Domestic and international travel may be required. Celerion values integrity, trust, teamwork, and respect.

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
• Self-motivation
• 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

Responsibilities

• Oversee and coordinate pre-study deliverables (e.g. populate CRA scope of work template, site qualification visit waiver, etc.)
• Prepare and ensure delivery of the study specific Clinical Monitoring Plan
• Prepare and ensure delivery of documents for Site Initiation Visits (SIVs) (e.g. presentation slides)
• Provide training materials to the clinical monitoring team and ensure training is documented and tracked
• Perform content review and quality checks of received documents
• 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 in audits and inspections, including preparation and follow-up activities
• Support in Celerion process improvement
• Perform in-house tasks according to instruction of the Manager of Clinical Monitoring and according to contractual agreements with Sponsor/Client
• Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific)
• Interact with his/her supervisor to develop a thorough and unambiguous understanding of all tasks required as well as project/study timelines and priorities
• Contribute to Celerion's continuous improvement efforts
• Maintain a working knowledge of all required Celerion IT systems
• Perform other functions as assigned by Manager of Clinical Monitoring
• Perform other functions and billable or non-billable tasks as assigned by GCD Operational Management
• Follow administrative and reporting/documentation requirements of Celerion and clients, as necessary
• Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates
• Perform tasks in other functional areas as necessary

Benefits

Remote work