Clinical Research Associate (GFR-L) Regional Travel
As you develop your career as a CRA, this role offers you the opportunity to plan and progress your career in the direction you choose. At Quintiles, we do not believe in a ‘career ceiling.’ You can make the Senior CRA role a stepping-stone into wider opportunities like operations management, dedicated customer solutions, and project management. And you won’t do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.
Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You will be building a smart and flexible career with no limits.
While projects vary, your typical responsibilities might include:
- Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
- Supporting the development of a subject recruitment plan
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites
- Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- 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 to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
- 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.
- 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.
- Act as a mentor for new clinical staff.
- May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
You should have:
- A Bachelor’s degree in a health care or other scientific discipline or educational equivalent
- At least 12 months of on-site monitoring experience
- Experience in any complex therapeutic area
- Alternatively, you should have an equivalent combination of education, training and experience
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
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Quintiles 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.
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