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Clinical Research Associate II / Senior CRA

🕒 24 days ago
Clinical Trial MonitoringPhase 2/3 TrialsOncologyRare Disease
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📜 Description

  • Conducts pre-study, initiation, interim, and close-out monitoring visits on-site or remotely.
  • Assesses whether investigational sites have the facilities, staff, equipment, and resources needed to conduct studies.
  • Trains investigational site staff as needed.
  • Supports regulatory and ethics committee submissions when applicable.

🛠️ Requirements

  • 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 such as oncology / 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
  • Identifies investigators and verifies their qualifications and ability to conduct the study throughout its duration.
Full 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

  • National Travel Required
  • 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 conducting the clinical study throughout the study period.
  • Trains investigational site staff as necessary
  • When applicable, supports preparation of regulatory and / or EC submissions

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 such as oncology / 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

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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