Remote Clinical Trials Site Activation Coordinator

Indero; Buenos Aires; Presencial; ARS 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible work schedule / home-based

Ongoing learning and development

Descripción de la vacante

Indero, a CRO specialized in dermatology and rheumatology, seeks a Project Coordinator to provide administrative and coordinating support for site activation activities throughout the clinical trial lifecycle.

You will work with Project Managers, Clinical Trial Managers and CRA teams to ensure timelines, targets and quality meet expectations. Home-based role with learning and development opportunities.

Formación

• Bachelor’s degree in a field relevant to clinical research or equivalent experience.
• Specialized graduate diploma in drug development is an asset.
• Experience in clinical research and in biotechnology/pharmaceutical/CRO industry is an asset.
• Excellent oral and written skills in English; French is an asset.
• Excellent knowledge of Word, Excel and PowerPoint.

Responsabilidades

• Prepare Investigator Sites to conduct clinical trials through review and approval of essential clinical trial and regulatory documents.
• Establishes site activation timelines with selected sites and coordinates activities to meet planned activation timelines.
• Communicate with clinical sites during site start-up.
• Collaborates with other functional departments to ensure alignment of activities to meet site activation targets.
• Escalates to the Project Manager risks to site activation schedule.
• Communicates with study teams and external site staff to align tasks with study timelines.
• Collects, reviews and files sites essential documents.
• Ensures that regulatory documents are complete for site activation and ongoing study management.
• Maintains eTMF with relevant regulatory documents for site activation.
• Distributes study documents between sites.
• Produces meeting minutes from project meetings.
• Assists with training and reconciliation of training.
• May assist with drafting study documents and study plans.
• Acts as main contact for site correspondences for non-protocol issues.
• Assists with ethics submissions and access to study systems.
• Maintains study files and study material inventory.
• Prepares shipments of study supplies to sites.
• Assists with Investigator’s Meeting preparations and study correspondence.

Conocimientos

Excellent English

Oral and written communication

Microsoft Word

Microsoft Excel

PowerPoint

Attention to detail

Organizational skills

Multitasking

Educación

Bachelor’s degree in a field relevant to clinical research or equivalent experience

Specialized graduate diploma in drug development (asset)

Herramientas

Word

Excel

PowerPoint

Descripción del empleo

Indero, a CRO specialized in dermatology and rheumatology, seeks a Project Coordinator to provide administrative and coordinating support for site activation activities throughout the clinical trial lifecycle.

You will work with Project Managers, Clinical Trial Managers and CRA teams to ensure timelines, targets and quality meet expectations. Home-based role with learning and development opportunities.