Lead Clinical Research Associate (LCRA)
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Lead CRAs will be assigned to different studies conducted in one or more countries to deliver and progress the assigned studies.
The Lead CRAs will also be assigned as CRA to one study site as a minimum to verify an adequate understanding of sponsor requirements procedures and systems. Thus requiring the CRA to have more than 3-5 years of onsite monitoring experience. Previous roles and experience in clinical lead would be beneficial.
The main responsibilities of the Lead CRA are:
- To oversee the overall study monitoring plan compliance for the studies and countries assigned.
- To serve as the primary point of contact for IQVIA CRAs and sponsor Project manager for any study monitoring-related questions or concerns.
- To provide oversight of site monitoring data management activities (entails pulling data management reports and leading the follow-up on missing pages outstanding queries etc.).
- To review Monitoring Visit Reports and advise CRAs on any study-related questions. Initially 100% MVR review is expected moving in the future to a risk-based approach after consultation and agreement with sponsor Project Manager.
- To prepare lead and follow up on regular meetings (frequency to be determined by the Project Manager and Lead CRA for each of the studies) with the IQVIA CRA and sponsor Project Manager to review study status risks trends upcoming data timelines etc.
- To collaborate and liaise with sponsor Project Manager for project execution support as appropriate.
- To support CRA with study issue resolution.
- To report any staff performance concerns to the CRAs manager.
IQVIA 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
Required Experience:
IC
Key Skills
- CSS
- Cloud Computing
- Health Education
- Actuary
- Building Electrician
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
