Experienced Clinical Research Associate, Real World Evidence
The IQVIA Real World Evidence (RWE) team helps our customers to deliver Real-World and late phase studies faster with a specialized operational team, processes and high technologies. As a CRA for Real World Evidence, you will balance relationships between on site and remote monitoring to improve delivery and quality. We seek dynamic and motivated people who truly want to make a difference in the life sciences industry. At IQVIA, we look for the very best people and give them meaningful work to do. We don’t simply think about careers, we think about contributions.
What we Offer:
- Excellent salary and benefits package
- Flexible working hours in our office at La Défense, France.
- As a CRA, you will receive a company iPad and have use of key developments such as site visit apps, visit reporting apps which allow CRAs to do their day to day job more efficiently!
- We invest in keeping our teams stable, so workload is consistent
- We offer genuine career development opportunities for those who want to grow as part of the organisation
- We give the chance to work on cutting edge medicines, right at the forefront of new medicine development
- Usually allocated to 4-6 protocols (likely to be in the areas of Oncology, Neurology, Rare diseases, cardiology….)
- Responsible for approximately 30 sites
- On site about 5 days per month,
- Permanent employment contract
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Review, prepare and negotiate site contracts and budgets with sites, if applicable.
- Perform Site Selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. 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. Escalate quality issues as appropriate.
- 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.
- 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.
- Collaborate and liaise with study team members for project execution support as appropriate.
We believe in hiring the best talent in the industry.
To become part of our team, you should:
- Have a degree in Life Sciences or have equivalent experience
- Have at least 1,5 year of independent on-site monitoring experience
- Strong therapeutic and protocol knowledge
- Strong ICH GCP and applicable clinical research regulatory requirements knowledge
- Hold a full French and clean driving license
- Possess strong communication, written and presentation skills are a must (must have fluency in English language)
- With the merger between Quintiles and IMS Health, we now have access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. It’s the next generation of clinical development
- Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
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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