Project Coordinator
Linical
Summary
Clinical Ink is seeking a Project Coordinator to join our Project Management team based remotely across the United States! The Project Coordinator will be responsible for supporting Project Managers within assigned programs and accounts.
Job description
Responsibilities
- Assist in the development and management of project plans, including timelines, communication plan, training plan, data transfer plan, content documents and implementation plans
- Coordinate and manage the study change control process from initial request to final decision/approval, including documentation and communication
- Plan and participate in internal and external meetings, including preparing minutes and associated materials
- Liaise with internal functional teams and resources to carry out project requirements/tasks
- Liaise with external teams to achieve project objectives in and around change controls, translations, content development, and integrations
- Assist with managing and updating timelines
- Coordinate and work closely with Study Support and Implementation to ensure sites, users, and equipment requests are addressed and entered in a timely fashion
- Perform configuration activities for identified projects, as needed
Qualifications
- Four-year college degree or equivalent combination of education and work experience
- 1+ years of clinical trials experience within a Clinical Research Site, CRO or eClinical service provider in a project management role or other equivalent experience
- Experience working with clients, ability to communicate to varying levels of personnel
- Experience working in data collection and management systems
- Excellent verbal and written communication skills
- Experience working on global projects and cross functional teams
- In depth understanding of clinical trials
- Working knowledge of software delivery lifecycle and methodology
- Working knowledge of GCP, ICH guidelines and relevant FDA regulations
Requirements
- Four-year college degree or equivalent combination of education and work experience
- 1+ years of clinical trials experience within a Clinical Research Site, CRO or eClinical service provider in a project management role or other equivalent experience
- Experience working with clients, ability to communicate to varying levels of personnel
- Experience working in data collection and management systems
- Excellent verbal and written communication skills
- Experience working on global projects and cross functional teams
- In depth understanding of clinical trials
- Working knowledge of software delivery lifecycle and methodology
- Working knowledge of GCP, ICH guidelines and relevant FDA regulations
Company overview
Linical is a global Contract Research Organization (CRO) that provides comprehensive drug development services from early-phase research to large-scale multinational clinical trials. Founded in Japan and celebrating over 20 years of operation, the company has established itself as an award-winning CRO with a significant presence across all major markets including North America, Europe, and Asia-Pacific. With nearly 1,000 employees operating in 30+ countries, Linical offers a full spectrum of clinical development services including drug development strategy, clinical trial management, regulatory affairs, and therapeutic expertise across oncology, neurology, immunology, endocrinology, and other therapeutic areas. The company is recognized for its personalized approach to clinical trials, maintaining an impressive 85%+ client retention rate and consistently exceeding enrollment goals. Linical's operational model combines strong business perspective with clinical and medical expertise, providing flexibility and strategic guidance to help biopharmaceutical companies successfully navigate complex regulatory challenges and bring promising new therapies to patients worldwide.