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Senior Clinical Research Associate

Role overview

Qualifications

  • College/University degree in Life Sciences or equivalent experience
  • Extensive on-site monitoring experience in phase 2/3 trials, ideally in oncology or rare disease
  • Full working proficiency in English
  • Ability to plan, multitask and work in a dynamic team environment

Responsibilities

  • Perform on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities
  • Identify investigators and verify qualifications, resources, facilities, equipment, and staff adequacy
  • Train investigational site staff as necessary
  • Mentor/training of new staff and perform co-monitoring visits

Key facts

Other skills

  • Mentorship
  • Communication
  • Collaboration
  • Problem Solving
  • Planning
  • Multitasking
  • Teamwork

About the company

PrimeVigilance logo

PrimeVigilance

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

Company size501 - 1000

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Job description

Company Description

Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.   

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia  

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.   

We have nourished a true international culture here at Ergomed.   

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

  • Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study 
  • Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period. 
  • Trains investigational site staff as necessary 
  • When applicable, supports preparation of regulatory and / or EC submissions 
  • Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance. 

 

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience 
  • Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease 
  • Full working proficiency in English 
  • Ability to plan, multitask and work in a dynamic team environment 
  • Communication, collaboration, and problem-solving skills 
  • Ability to travel nationally 

Additional Information

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 is a great company to join!   

Quality  

Integrity & Trust   

Drive & Passion   

Agility & Responsiveness   

Belonging  

Collaborative Partnerships   

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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