Study Start-up Clinical Research Associate
1 month ago
Als SSU CRA ben je verantwoordelijk voor het hele proces voor 'green light'.
Waar houdt onze sponsor zich mee bezig?
Onze partner doet onderzoek in verschillende therapeutische domeinen zoals immunologie, solide tumoren, ophthalmologie, respiratoir, dermatologie, cel- en gentherapie, hematologie, neurologie en hart- en vaatziekten. Het gaat om alle klinische fases van geneesmiddelonderzoek.
Onze sponsor is koploper in wetenschappelijke en klinische studies. Dankzij het positieve klimaat voor klinische ontwikkeling, de innovatieve infrastructuur en ervaren medische teams is België hier een belangrijk centrum voor.
Wereldwijd heeft onze sponsor zo'n 150 entiteiten in de pipeline, in België worden er zo'n 100-tal studies gerund.
De 2.500 patiënten verspreid over 580 centra spelen dan ook een cruciale rol. Belgische patiënten zijn betrokken bij het vroege onderzoek van bijna elk geneesmiddel dat ontwikkeld wordt. Omdat we in België veel klinisch onderzoek doen komen er niet alleen nieuwe geneesmiddelen op de markt, maar biedt men patiënten ook eerder toegang tot nieuwe of extra behandelingsmogelijkheden.
In welke omgeving kom je terecht?
Je komt terecht in een team van een 15-tal CRA's, waarvan 3 SSU CRA's. Samen met de trial managers en CTA's brengen zij de klinische studies tot een goed einde. Soms werk je als CRA alleen op een studie, maar voor grotere studies werken we met meerdere CRA's. Tijdens het Trial Team Overleg wordt de voortgang van de studie besproken. Dit kan remote, maar kan zeker ook op kantoor te Vilvoorde.
Iedereen heeft een homebased contract. Je kan dus van thuis uit werken wanneer je wil. Wel wordt er verwacht aanwezig te zijn op kantoor voor trainingsdagen, sociale activiteiten, ...
Enkele van onze CRA's gaan heel graag naar kantoor in Vilvoorde. Zij spreken dan ook samen af om dezelfde dag naar kantoor te gaan.
Hou jij van gezellig samenkomen? SUPER Dit TEAM ook
Naast de maandelijkse 1-to-1, organiseren de line managers en collega's ook graag een leuk event (drink, karaoke,...)
In een gezamenlijke agenda wordt ook de aanwezigheid op kantoor aangegeven, zodat je als team kan samenkomen. Tijdens de middag eten zij dan samen een lunch, tenmidden van een gezellige koffieklets
Jouw ontwikkeling is uiteraard onze grootste bezigheid Onze line managers luisteren graag naar jouw toekomstvisie, wat je graag anders ziet en geven jou hier graag advies in.
Wat houdt je job precies in:
Als SSU CRA ben je verantwoordelijk voor de relaties met de sites. Je zorgt voor een duurzame start van de studie. De Study Start-Up CRA selecteert de sites en coordineert de opstartactiviteiten:
- Je ondersteunt de nationale SSU strategie
- Je coordineert start up activiteiten om ervoor te zorgen dat timelines en deliverables worden gehaald.
- Verantwoordelijk voor tijdige opstartactiviteiten vanaf de toewijzing van het land tot aan de greenlight van de site.
- Voert bezoeken voor siteselectie uit, controleert of de site in aanmerking komt voor een specifieke studie
- Belangrijkste contactpersoon voor onderzoekslocaties tijdens de selectie van de locatie, het opstarten van de studie en de indieningen
- Verzamelt indiening van relevante locatie-specifieke documenten
- Ondersteunt de voorbereiding van financiële contracten
- Werkt alle systemen voortdurend bij tot de site groen licht krijgt
- Ondersteunt de voorbereiding van audits en inspecties, indien van toepassing
Naar wie zijn wij op zoek?
Jij hebt een hart voor klinische studies, dat merkt iedereen aan de gedrevenheid en het enthousiasme die jij elke dag laat zien.
Je passie voor je vak ontdekte je tijdens je Bachelor of Master in biomedische wetenschappen, verpleegkunde, geneeskunde, kinesitherapie of een andere gerelateerde richting.
Je hebt minimaal 3 jaar werkervaring in het monitoren van klinische studies.
Je kan je goed uitdrukken in het Nederlands, Frans en Engels.
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-Hybrid
#LI-VV1
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