Clinical Research Associate

1 settimana fa

Verona, Italia Alira Health A tempo pieno

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.

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.
- CRA certification according to the MD 15/11/2011.
- Previous experience as CRA with independent monitoring experience of (at least) 4 years.
- Fluency in English and Italian is a must.
- 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.

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