Junior Expert Drug Regulatory Affairs (m/w/d) Bad Homburg vor der Höhe Vollzeit Fresenius Medical Care Contracts Associate Deutschland Vollzeit ICON Clinical Associate Frankfurt am Main Vollzeit Icon plc
Jetzt als Clinical Research Associate II bei ICON in Homeoffice bewerben – Deine Chance!
×
ICON
Homeoffice
Stellenausschreibung
As a Clinical Reserach Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
- Key Responsibilities
Study Planning
- Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
- Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators.
- Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
- Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure adherence to payment schedule.
Study Start-up
- Execute site initiation and training, generate initiation visit report
Study Execution
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
- Identify problems at sites; resolve issues and escalate as appropriate.
- Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
- Complete preparation and generation of visit monitoring reports as per relevant SOP
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
- If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
Study Close-out
- Implement site close-out activities and generate site close-out report.
- Provide feedback on site performance for future trial site feasibility/selection
To Be Successful in The Role You Will Have
- Working Knowledge of Local Regulations and ICH/GCP Guidelines, minimum 2 years monioring experience
- Fluent in English/ German both written and oral
- Familiarity with Risk Based Monitoring approach
- Experience conducting Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely (if applicable to the region) and on-site
What is Offered
- Permanent contract
- Contribution to pension scheme
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.
Weitere Stellenangebote
Prämium Inserate
Clinical Site Monitor I/ II - FSP/ Germany/Homebased
Home Office
Clinical Trail Administrator, CTA Finance
München
CRA I/ CRA II
Home Office
Clinical Research Associate (Germany)
München
Ähnliche Stellenangebote
Clinical Research Associate (m/w/d) Hamburg Vollzeit AstraZeneca Mitarbeiter (m/w/d) Versand / Logistik Weil am Rhein Vollzeit Thermo Fisher Scientific