CRA - Norway
Descripción del trabajo
The IQVIA 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
- Fluent local language
- Organizational and problem-solving skills.
- Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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