Clinical Research Coordinator
Thermo Fisher Scientific
Summary
Join us as Clinical Research Coordinator - And manage the day-to-day operations of our clinical trials.
Job description
What You'll Do
- Conduct multiple ongoing clinical trials, of varying size and complexity, involving patients or healthy volunteers/subjects.
- Complete all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interact with the research site team and other interdepartmental staff.
- Engage in the entire site operations process, which includes recruitment, enrollment and retention of study participants.
- Provide training and guidance to junior team members. Acts as a lead coordinator for certain studies, taking the overall responsibility thereof at the site, liaising with monitors and other stakeholders.
Education and Experience
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years). 1+ year of leadership responsibility.
- In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities
- Directly supervises individual contributors, administrative support and / or entry-level professionals.
- Fundamental communication and interpersonal skills with the ability to manage, motivate and mentor staff
- Strong organization skills with ability to handle multiple tasks simultaneously, meet rigorous timelines and work effectively in stressful situations
- Understanding of budgets, project planning and performance metrics
- Strong English and grammar skills, second language a plus
- Sound knowledge of taxonomies (e.g. folder structures, metadata, user access) and/or Records Management principles including but not limited to: FDA Good Clinical Practices; ICH Guidelines and PPDs Standard Operating Procedures and Working Practice Documents; retention schedules; Legal Holds; supporting software and/or PPD's eTMF process and the DIA eTMF Reference Model
- Sound knowledge of organization's archival processes and systems (hardware, software, applications, operating systems, basic programming languages, etc.)
- Ability to manage the day-to-day operation of Records Management file rooms including but not limited to document control, security and audit preparedness
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years)
- 1+ year of leadership responsibility
- Fundamental communication and interpersonal skills with the ability to manage, motivate and mentor staff
- Strong organization skills with ability to handle multiple tasks simultaneously, meet rigorous timelines and work effectively in stressful situations
- Understanding of budgets, project planning and performance metrics
- Strong English and grammar skills
- Sound knowledge of taxonomies and/or Records Management principles including FDA Good Clinical Practices; ICH Guidelines and PPDs Standard Operating Procedures and Working Practice Documents; retention schedules; Legal Holds; supporting software and/or PPD's eTMF process and the DIA eTMF Reference Model
- Sound knowledge of organization's archival processes and systems
- Ability to manage the day-to-day operation of Records Management file rooms including document control, security and audit preparedness
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.