IQVIA
Job title:
Senior Clinical Research Associate
Company:
IQVIA
Job description
IQVIA is a leading global provider of contract research services, advanced analytics and technology solutions to the life sciences industry formed through the merger of IMS Health and Quintiles.Take your therapeutic expertise to the next level and help drive the evolution of clinical development for a variety of sponsors.As a Clinical Research Associate within our full-service model, you’ll have the opportunity to embrace your passion for a specific therapeutic area and work with cutting-edge technology developed specifically for CRAs by CRAs.With access to world-class training and professional development, we’ll give you the tools you need to create the career you want.Do you want to know more about IQVIA? then see what Forbes said about us!Essential Functions of a Clinical Research Associate (CRA)
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Qualifications
- Bachelor’s Degree or Master’s Degree, ideally in scientific discipline or healthcare
- Knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Minimum of 12 months of independent monitoring experience
- Written and verbal communication skills including excellent command of English and Dutch language
IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.#CRAFSAJDIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Expected salary
Location
Amsterdam, Noord-Holland
Job date
Thu, 17 Oct 2024 22:09:22 GMT
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