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Clinical Trial Assistant II

Role overview

Qualifications

  • Must have at least 1 year of Clinical Trial Assistant experience
  • 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)

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 with the PM/CTM and supports preparation of meeting agenda
  • Maintains contact lists, information for project team members and other trackers as required

Key facts

  • Remote from: Canada
  • Full time
  • Mid-level (2-5 years)
  • English

Other skills

  • Microsoft Office
  • Communication
  • Multitasking
  • Teamwork
  • Physical Flexibility

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

Medicine moves forward here. So will you. 

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.  

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait. 

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported. 

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you. 

 

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

  • Must have at least 1 year of Clinical Trial Assistant experience. 
  • 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

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. 

  • Quality: we hold ourselves to the standard patients deserve. 

  • Integrity and trust: we do the right thing, especially when it is hard. 

  • Drive and passion: we care about the outcome, because someone is waiting on it. 

  • Agility and responsiveness: we move quickly, because patients cannot wait. 

  • Belonging: everyone is welcome, and every voice counts. 

  • Collaborative partnerships: we go further by going together. 

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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