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Clinical Trial Coordinator Specialist
Há 1 mês
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Salary and BenefitsThe estimated salary for this role is between $60,000 and $80,000 per year, depending on experience and location.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Job DescriptionThis is an exciting opportunity to join our global Clinical department as a , where you will provide administrative and technical support to the Project Team.
You will oversee and complete functions on assigned trials activities detailed on the task matrix, ensuring allocated tasks are performed on time, within budget and to a high-quality standard.
You will also perform department, Internal, Country and Investigator file reviews as assigned and document findings in appropriate systems.
Additionally, you will support the maintenance of study specific documentation and systems, including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate systems.
You will provide system support ( GoBalto & eTMF) and assist with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
You will also assist with study-specific translation materials and translation QC upon request.
Required Skills and Qualifications- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
- Bachelor's degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
You must have fluency in English and Portuguese is essential.
Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
You should be self-motivated, positive attitude and good interpersonal skills.
Key Responsibilities- Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
- Supports the maintenance of study specific documentation and systems.
- Provides system support ( GoBalto & eTMF).
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Ability to work in a team or independently as required.
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
- Strong customer focus.
- Flexibility to reprioritize workload to meet changing project timelines.
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout.
- Fluency in English and Portuguese is essential.
- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
