Do you want to make an impact as Clinical Research Professional? Do you want to protect the safety & well-being of subjects and guarantee data quality? Do you get energy from daily communication with investigators, study coordinators and study teams? Do GCP ICH E6 R2 and ISO 14155 have no secrets anymore for you? You might be the Clinical Research Associate we are looking for!
What do we expect from you as a Clinical Research Associate?
The Clinical Research Associate is responsible for site management related to clinical trials in different phases and therapeutic areas, ensuring that milestones, timelines and quality of such trials, as outlined by the study protocols, monitoring plans, SOPs, and applicable regulations and policies are met.
Main Responsibilities:
- Initiates, monitors and closes study sites in compliance with procedural documents. Shares information on patient recruitment, study site progress and escalates any issues
- Ensures that the rights and well-being of subjects are protected and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements
- Obtains and updates essential documentation
- Trains, supports and advises investigators and site staff about study-related matters in order to ensure compliance
- Conducts and reports periodic monitoring visits
- Carries out source data verification (SDV) according to the monitoring or SDV plan and ensures data query resolution.
- Manages study supplies and track the device/drug accountability at the study sites
- Cooperates with the site staff for ensuring a proper reporting from the site of the safety events (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up.
- Prepares activities related to audits and regulatory inspections
- Participates in the development and coaching of less experienced CRAs
Who are we looking for?
- You have a Bachelor or Master degree in biological or (para-) medical sciences
- Minimum of 4 years’ experience in clinical research or equivalent by education or relevant experience
- You have a critical mindset, excellent communications and organizational skills
- Ability to maintain composure in difficult circumstances
- Fluent in Dutch, French and English. Other language are a plus.
- A true QbD’er can be recognised by the following qualities:
- Resilient: Your strong and positive attitude helps you overcome any challenge
- Hungry for knowledge: You are always open to learning
- No BS mentality: you can be straightforward in a respectful way
- Innovative: You are constantly looking for new and better solutions
- (Not too) serious: your job is serious, but you don’t take yourself too serious.
What’s in it for you?
- QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
- Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
- As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
- Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together
- Our promise to you:
- As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences
- Moreover, we aim to create a?joyful community?where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
- In short … We stand for?JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!