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Senior Clinical Research Associate

Role overview

Qualifications

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

Responsibilities

  • Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities
  • Identifies the investigators and verifies their qualifications, resources, facilities, and staff throughout the study period
  • Trains investigational site staff as necessary
  • Participates in mentoring/training of new staff and performs co-monitoring visits to assess junior staff performance

Key facts

Other skills

  • Training And Development
  • Communication
  • Collaboration
  • Problem Solving
  • Multitasking

About the company

ERGOMED logo

ERGOMED

Pharmaceuticals

Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. The Ergomed group employs over 1,800 people and operates out of 24 offices around the world, providing its services to researchers and patients in around 100 countries globally. Our Ergomed Clinical Research business was founded in 1997 and provides high-quality clinical research and trial management services globally and across all trial phases (I to IV), specialising in oncology and rare disease trials. We use innovative site-support services which focus on enhancing patient recruitment and engagement, with a strong heritage in Europe and the USA. PrimeVigilance is a global leader in pharmacovigilance and specialised multi-lingual medical information services. Since 2008, the PrimeVigilance business has supported pharmaceutical, biotechnology and genetics companies in managing the global safety of their products, all the way from clinical trial to post-marketing. Our pharmacovigilance services include case processing, signal and risk management, pharmacoepidemiology, audits, training, advisory literature services, medical information and QPPV.

Company details

Company typeLarge
IndustryPharmaceuticals
Company size1001 - 5000

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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

  • 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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