CRA, Denmark (BB-8E53E)
Found in: Searcheuropeanjobs
Description:The IQVIA FSP team are changing the life science industry through inspired innovation. Our people make a difference. You could be part of a team that work on exciting complex studies for one single sponsor dedicated program! We are looking for a CRA who cares and wants to make a difference in the life science industry.
**Responsibilities and duties**
+ Working as a CRA you would act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
+ Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
+ Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
+ Gains an in-depth understanding of the study protocol and related procedures.
+ Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
+ Participates & provides inputs on site selection and validation activities.
+ Performs remote and on-site monitoring & oversight activities.
+ Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
+ Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
+ Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
+ Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
+ Must have minimum of 1 year onsite monitoring experience
+ Life science degree / relevant work experience
+ Strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
+ Good therapeutic and protocol knowledge as provided in company training.
+ Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
+ Problem solver
+ Organizational and problem-solving skills.
+ Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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