Careers
| Business Title |
Clinical Research Associate
1
Job Describtion on request.
|
| Requisition ID | 223345/Biel |
| Job Category | Clinical Research |
| Locations | Belgium/Netherlands/Europe |
| Shift | 1 |
| Job Description |
CLINICAL Research ASSOCIATE
Office based in Belgium Bielderman manages over 32 clinical trial protocols in 16 countries. To sustain our growth, we continue to invest significantly in new facilities around the globe. Job Duties and Responsibilities: Site management responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP. Review progress of projects and initiate appropriate actions to achieve target objectives. Hands on the job; this means availability during Operations in participating hospitals for Medical Device studies in Europe. Traveling time: 30%
Report, write narratives and follow-up on serious adverse experiences. Interact with internal work groups to evaluate needs, resources and timelines. Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors and other duties |
| Education/Qualifications | Typically required: University degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). Candidates with similar experience within the field of clinical research are welcome to apply as well. Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements. Basic understanding of the clinical trial process. Fluency in English and French A valid drivers license. |
| Experience | Typically required : No Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines. Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Good planning, organization and problem solving abilities. Good communication and interpersonal skills. Good analytical and negotiation skills. Computer competency. |