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? Do you like to perform monitoring visits in hospitals? Do you want to be surrounded by fantastic colleagues in an authentic and growing company and be one of our ambassadors? You might be the Clinical Research Associate we are looking for!
- Employment type: Full time
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.
- Initiates, monitors and closes study sites in compliance with procedural documents and taking into account the quality standards and timelines.
- Shares information on patient recruitment, study site progress and escalates any issues to the study team
- Ensures that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, 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 in compliance with ISO/GCP, Procedural Documents and local regulations
- Trains, supports and advises investigators and site staff about study-related matters in order to ensure compliance
- Is in charge of performance at the site.
- Proactively identifies study-related issues and finds the appropriate solutions independently or in cooperation with the study team lead
- Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP’s and ISO/GCP requirements in order to ensure data integrity and subject safety
- Carries out source data verification (SDV) according to the monitoring or SDV plan.
- Ensures data query resolution.
- Prepares monitoring reports and confirmation / follow-up letters in a timely manner
- 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, guaranteeing timely and appropriate handling of safety issues
- Actively participates in project team meetings
- Prepares activities related to audits and regulatory inspections together with the Project Leader and/or Project Manager
- May interact with vendors, as required
- Uses discretion, diplomacy and tact to resolve difficult situations.
- Escalates serious issues to management.
- Participates in the development and coaching of less experienced CRAs
Who are we looking for?
- Master degree in biological or (para-) medical sciences or equivalent by experience
- Minimum of 4 years’ experience in clinical research or equivalent by education or relevant experience
- Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
- Demonstrates ability to make timely and well-reasoned decisions
- Demonstrates ability to effectively and persuasively communicate verbally and in writing
- Demonstrates ability to identify and adapt to shifting priorities and competing demands
- Ability to maintain composure in difficult circumstances
- Fluent in Dutch, French and English. Other language are a plus.
A true QbD’er can be recognized 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 does QbD Group offer you?
- An attractive and complete salary package:
A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.
But most of all…
- We offer sustainable careers and meaningful connections
- We are a knowledge based company
- You’ll work for an award winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, …
- Find out more on our website
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.
We’ve got your back, giving you the opportunity to shape your career.
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!
Send us your CV and motivation letter (both in English) and who knows, we might welcome you soon in our QbD group! To apply for this job email your details to firstname.lastname@example.org