Clinical Research Associate
5 mesi fa
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
Position Description:
The CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRAs are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out.
**Job Description**:
Principal Responsibilities Include:
- Establishing high
- impact communication lines with assigned Investigators, administering study related training, fostering a partnership approach and facilitating study conduction
- Evaluating the quality and integrity of site practices - managing quality issues as appropriate
- Maintaining oversight on site related activities throughout the life cycle of project performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
Skills and Experience Required:
- Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.
- Previous experience as CRA with independent monitoring experience of (at least) 5 years.
- Fluency in English and Italian
- Must be able to travel in accordance with company and project requirements.
- Good interpersonal skills demonstrated as proactive, enthusiastic, and independent thinker.
- Experience working in a self-driven capacity and with a sense of urgency.
- A client-focused approach to work and flexible attitude with respect to assignments/new learning.
- An honest and ethical work approach to promote the development of life changing treatments for patients.
- Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), eCRF and MS-Office products such as Excel and Word.
Languages
Dutch, English
Education
Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Pharmacology, Bachelor of Science (BS): Pharmacy
Contract Type
Regular
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