Youth Activities Host & Program Coordinator

Navegacruceros.Com; Santiago; Presencial; CLP 12.000.000 - 18.000.000; Jornada completa

Descripción de la vacante

ThermoFisher Scientific is seeking a Bench Clinical Trial Coordinator in Santiago to support study start-up, execution, and close-out. The role involves document collection, regulatory submissions, and close collaboration with investigators and CRAs.

Responsibilities include maintaining eTMF/ISF, ensuring inspection readiness, and supporting study materials and meetings. Strong English and local language skills, plus MS Office proficiency, are required.

Formación

• High/Secondary diploma or equivalent and relevant qualification.
• Bachelor's degree preferred for advanced roles.
• 2+ years of experience in clinical study administration or related field.

Responsabilidades

• Assists in coordination and administration of clinical studies from start-up to close-out.
• Collects and tracks documents for regulatory submissions and EC/IRB processes.
• Interfaces with investigators, service providers and CRAs during document collection.
• Acts as local administrative contact with CRAs and LSAD for the study.
• Maintains local eTMF and ISF per ICH-GCP and local rules.

Conocimientos

Teamwork

Organizational skills

Attention to detail

Customer focus

Flexibility

Regulatory knowledge

English skills

MS Office

Clinical trial databases

Clinical training

Educación

High/Secondary diploma

Bachelor's degree preferred

Herramientas

CTMS

SharePoint

Descripción del empleo

FSP Bench Clinical Trial Coordinator

Santiago ThermoFisher Scientific

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator / Clinical Study Administrator - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You’ll Do:

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System, ensuring compliance with the company-approved authoring guide for regulatory documents.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
• Sets-up, populates and accurately maintains information in company tracking and communication tools (e.g. CTMS, SharePoint, etc.) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
• Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
• Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
• Manages and contributes to coordination and tracking of study materials and equipment.
• Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
• Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors' meetings, Investigators' meetings. Liases with internal and external participants and/or vendors, in line with international and local codes.
• Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites.
• Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.
• Ensures compliance with the company Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Ensures compliance with local, national and regional legislation, as applicable.
• Additional country-specific tasks might be added depending on local needs

Education and Experience Requirements:

• 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 +2 year).
• 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:

• 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
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete the organizations clinical training program
• Self-motivated,