Clinical Monitoring Coordinator

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.  

Celerion is hiring for a full-time remote Clinical Monitoring Coordinator in the United States.  Travel may be required domestically and/ or internationally for this position.  

The Clinical Monitoring Coordinator will assist with clinical monitoring services by supporting in-house activities for studies or projects monitored by Celerion.  The primary role of the Clinical Monitoring Coordinator is to support the responsible Manager of Clinical Monitoring and their designates in oversight tasks as well as Clinical Research Associates (CRAs) during the initiation and implementation of studies or projects.

Essential Functions:

• 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

Additional Responsibilities:

• 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

Knowledge/Skills/Education/Licenses:

• 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

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.