Clinical Research Associate I

5 mesi fa

Roma, Italia Ora A tempo pieno

**POSITION TITLE**: Clinical Research Associate I

**DEPARTMENT **:Ora Europe

**LOCATION**: Italy

**_ Ora Values the Daily Practice of_**
- Prioritizing Kindness
- Operational Excellence
- Cultivating Joy
- Scientific Rigor_
- _______________________________________

**The Role**:
Ora's Clinical Research Associate I (CRA I) develops strong clinical site relationships and is accountable for performance and compliance with assigned protocols at our sites. Our CRA II's will work with the oversight of the Lead CRA's and Line Manager. As a CRA I, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross-functionally within Ora.

**What You'll Do**:

- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gain in-depth understanding of the study protocol and related procedures.
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
- Participate & provide input on site selection and validation activities.
- Perform remote and on-site monitoring & oversight activities using various tools to ensure:

- Data generated at site are complete, accurate and unbiased
- Subjects' right, safety and well-being are protected
- Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
- Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Travel Requirements up to 75%.
- Responsibilities may differ slightly from the above based on specific needs of the business.
- Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.

**What We Look For**:

- _Experience needed for the Role: _
- _Bachelor's degree with 1 years' experience in the clinical research field or equivalent combination of education, training, and experience. Years of experience may be considered in lieu of education._
- _Additional Skills & Attributes:_
- _Ophthalmic experience is strongly preferred._
- _Capacity to routinely assess protocol and GCP compliance._
- _Demonstrated ability to verify source data to reported data._
- _Strong attention to detail to review the completeness of the investigator site file. Knowledge to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visits._
- _Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs)._
- _Ability to read and demonstrate comprehension of a clinical research protocol as well as understand the importance of following the protocol._
- _Proficiency with Excel, CTMS, and EDC._
- _Multilingual communication is a plus._
- _Competencies and Personal Traits:_
- **Attention to Detail**: Ability to analyze available data and take the time to understand as full a picture as possible to drive successful solutions to complex problems.
- **Emotionally Intelligent Leadership**: Ability to lead with a positive mindset and empathy. Possess the capacity to understand others and to be aware of and sensitive to the feelings, thoughts, and experience of your colleagues and customers.
- **Intellectual **Curiosity**: A person's willingness and desire to learn new things and dig deeper than the surface. Intellectual curiosity makes learning a much more natural process, instead of just a duty or a chore. When you're intellectually curious, you're more willing and interested to acquire knowledge. You naturally ask more questions and seek to understand why things are the way they are.
- **Innovative Mindset**: Forward thinking, creative and open to testing, making mistakes and trying again; collaborative and progress-loving, you honor the past but embrace change because the new is always coming
- **Organization and Goal Setting**:Ability to set goals, delegate appropriate tasks, maintain a focused approach to critic

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