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Clinical Trial Assistant

Role overview

Qualifications

  • High school diploma or equivalent or adequate experience in the field of clinical research
  • Excellent English oral and written communication skills
  • Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project)
  • Administrative work experience, preferably in an international Clinical Research setting

Responsibilities

  • Carries out assigned administrative duties to support clinical trial conduct
  • Sets up Investigator Site File, according to SOPs provided either by the Sponsor or by ERGOMED, and distribute to sites
  • Coordinates and attends project meetings (e.g. investigator, kick-off, team, etc.) with the PM/CTM
  • Works with project teams to assist in tracking, naming and routing of clinical trial documentation to the Trial Master File (TMF)

Key facts

  • Remote from: Canada
  • Full time
  • English

Other skills

  • Microsoft Office
  • Planning
  • Multitasking
  • Teamwork

About the company

PrimeVigilance logo

PrimeVigilance

Contract Research Organizations (CRO)

PrimeVigilance, an Ergomed company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.From its operational hubs based in Europe, the USA, and Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.• 900+ highly qualified professionals• Global leader in QPPV services• 24/7 multilingual call center• Choice of leading drug safety databases• Robotic Process Automation (RPA) expertise• Access to regulatory experts and key opinion leadersGLOBAL LIFE CYCLE MANAGEMENT SERVICES• PHARMACOVIGILANCE • PHARMACOEPIDEMIOLOGY & BENEFIT-RISK MANAGEMENT• AUDIT & INSPECTION• QUALITY MANAGEMENT• REGULATORY SCIENCE

Company details

IndustryContract Research Organizations (CRO)
Company size501 - 1000

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Job description

Company Description

We are  Ergomed group, a specialised mid-size  service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.  

Ergomed provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.  

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.  

Come and join us in this exciting journey to make a positive impact in patient’s lives.   

Job Description

  • Carries out assigned administrative duties to support clinical trial conduct
  • Sets up Investigator Site File, according to SOPs provided either by the Sponsor or by ERGOMED, and distribute to sites
  • Coordinates and attends project meetings (e.g. investigator, kick-off, team, etc.) with the PM/CTM. Supports preparation of meeting agenda and provides written high-quality meeting minutes within specified timeframe
  • Works with project teams to assist in tracking, naming and routing of clinical trial documentation to the Trial Master File (TMF)
  • Maintains contact lists, information for project team members (e.g. project training records) and other trackers as required. Provides reports from tracking tools. 
  • If requested attends in-house audits and supports completion of Corrective and Preventative Action Plan 
  • Any other task related to the specific clinical trial performance

Qualifications

  • High school diploma or equivalent or adequate experience in the field of clinical research
  • Excellent English oral and written communication skills 
  • Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project)
  • Administrative work experience, preferably in an international Clinical Research setting

  • Ability to plan, multitask and work in a dynamic team environment

Additional Information

Why Ergomed  

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.   

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.  

We offer:  

  • Training and career development opportunities internally   

  • Strong emphasis on personal and professional growth  

  • Friendly, supportive working environment  

  • Opportunity to work with colleagues based all over the world, with English as the company language  

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed could be a great company to join!   

  • Quality  

  • Integrity & Trust   

  • Drive & Passion   

  • Agility & Responsiveness   

  • Belonging  

  • Collaborative Partnerships   

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.  

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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