As a Clinical Research Associate within Keyrus Biopharma, you will join a team on client's site to ensure site management, and compliance monitoring. This position involves primary: contact with health care professionals.
As a CRA you must ensure that all activities will be conducted in accordance with National/International Regulations, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP).
Role and main tasks:
The main missions are, eg:
- On site monitoring visits (selection, initiation, monitoring and close-out) according to Keyrus Biopharma or Client SOPs;
- Source data verification;
- Writing of study site visit reports;
- Maintenance of study files and administrative follow-up;
- Participation in the preparation of submissions to ECs;
- Ensuring, in compliance with GCP and SOPs, the quality, reliability and authenticity of data collected during monitoring;
- Review clinical sites progress and initiate appropriate actions to achieve target recruitment objectives.
Experience & Required skills:
- A first experience as CRA in Pharma/Biotech industry is mandatory (min 3 years)
- University Scientific Degree, Master: Biology, Bio-Medical Sciences, Bio Engineer or equivalent by experience
- Fast learner
- Attention to details
- Flexible, analytical and organized
- Team spirit
- Good interpersonal skills
- English: Excellent oral & written communication skills
- Dutch & French: fluent level in local languages
- Being familiar with ICH-E6 GCP guidelines before the interview. http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
What we offer
Who we are
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Chée de Louvain 88 - Waterloo-Lasne
- Rue Emile Francqui, 1 - Mont-Saint-Guibert
- Nijverheidslaan 3, - Strombeeck Bever