Clinical Research Associate I - Roma, Italia - Ora
Ora
Roma, Italia
Azienda verificata
2 settimane fa
Descrizione
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.
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 indepth 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 onsite monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects' right, safety and wellbeing are protected
- Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit & nonvisit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study startup, study maintenance and study closeout.
- 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:
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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.
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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.
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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.
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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
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Organization and Goal Setting:Ability to set goals, delegate appropriate tasks, maintain a focused approach to critic