Archer is a young, dynamic, and fast-growing Contract Research Organization (CRO) based in Bioville, Diepenbeek — a vibrant hub for health innovation.
We specialize in providing full support for clinical studies with medical devices in Europe.
As a you manage and conduct clinical studies in compliance with all regulatory requirements and Good Clinical Practice (GCP). You are the primary contact for investigational staff and are responsible for ensuring the quality and integrity of the clinical data. You will monitor multiple projects within different therapeutic areas, and you are able to work both independently and in a team environment.
You will have the opportunity to be involved in this constantly growing and inspiring international environment.
What is your role?
- Preparation and follow-up of ethical committee and/or national competent authority submissions in European member states.
- Select potential investigators by verifying the investigators’ interest, qualifications, training and resources, including investigational site facilities, equipment and staff.
- Conduct international pre-study visits, site initiation and study close-out visits to ensure data integrity and patient safety on site.
- Conduct clinical study monitoring (remote and on-site) to ensure adherence to the study protocol, Good Clinical Practice (GCP) in accordance with International Conference on Harmonization (ICH)-GCP standards, Declaration of Helsinki and Regulatory Requirements in order to guarantee data integrity, good documentation practice and patient safety.
- Support and advise investigators and site staff about study-related matters.
- Provide training to site staff as well as sponsor representatives about study-related matters.
- Coordinate planning and execution of investigator meetings.
- Assess and follow-up on patient recruitment and retention.
- Set-up and manage safety board and/or Imaging Core Lab.
- Ensure correct and timely Adverse Event (AE) and Serious Adverse Event (SAE) reporting and follow-up.
- Perform reconciliation of the Trial Master File (TMF) content to Investigator Site Files (ISF).
- Develop and manage (study-specific) clinical study documentation, including tools and templates.
- Keep track of the study budget.
- Create, implement, and adhere standard operating procedures (SOPs) for study execution.
Who are we looking for?
- You have experience as a Clinical Research Associate.
- You have a profound curiosity for clinical research & medical innovations.
- You are familiar with guidelines like Good Clinical Practice (GCP) and ISO standards (ISO14155, ISO9001).
- You’re familiar with EU regulations for medical devices (MDR) and the General Data Protection Regulation (GDPR).
- You have a Master's degree or Ph.D. degree in one of the Life Sciences.
- You love to travel and build strong (international) relationships with site staff, representatives and sponsors.
- You have excellent written and verbal communication skills including good command of English and of Dutch, German and/or French.
- You are able work predominately in our offices with the flexibility to work remotely from home.
- You’re confident, flexible, proactive, and result-driven, with attention to detail and accuracy in work.
- You excel in effective time management and organization, with the ability to manage multiple priorities across various clinical studies within various disciplines and with a problem-solving mentality.
- Computer skills, including working knowledge of Microsoft Word, Excel, PowerPoint and Electronic Data Capture (EDC) systems are checked in your competences list.
What do we offer?
At Archer Research, we don’t just support clinical studies — we empower careers. Here’s what you can expect when joining our team:
- A competitive salary package aligned with your experience and responsibilities, complemented by the following benefits: a company car, eco vouchers, a mobile phone with subscription, a comprehensive insurance package (including hospitalization, income protection and pension plan) and a Net flat-rate expense allowance to cover work-related costs.
- A close-knit team of passionate professionals and a flat hierarchy with direct access to leadership
- Opportunities to work on cutting-edge clinical research in medical devices that contributes directly to safer healthcare and patient well-being
- Continuous learning through internal coaching and external training
- A supportive environment that values well-being and autonomy
Interested in joining the Archer Research team? Do not hesitate to apply.
We would love to hear from you!
Job Types: Full-time, Permanent contract
Benefits:
- Company car
- Company classes
- Company computer
- Company phone
- Eco vouchers
- Fuel card
- Hospitalization insurance
- Life insurance
- Work from home
Work Location: Hybrid remote in 3590 Diepenbeek