Lead Clinical Research Associate

3 settimane fa

Roma, Lazio, Italia Ora A tempo pieno

**POSITION TITLE**: Lead Clinical Research Associate
**DEPARTMENT**: Ora Europe
**LOCATIONS**:Poland, Spain or Italy
**Ora Values the Daily Practice of **
- Prioritizing Kindness
- Operational Excellence
- Cultivating Joy
- Scientific Rigor_
At Ora, we are building the future of ophthalmic clinical research.
As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market.
Over the past 45 years, our expert teams have helped earn more than 85 new product approvals.
Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.
** **Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
**The Role**:
Ora's Lead Clinical Research Associate (Lead CRA) develops strong clinical site relationships and are accountable for hands-on delivery of project tasks in addition to delegation and oversight of more junior CRA's project tasks, providing advice and guidance to help achieve high performance and quality project deliverables.
Our Lead CRA's will work independently and partner with the CRA line Manager to ensure Ora's compliance with study conduct by monitoring the site activities regarding ICH/GCP and country regulations, Ora's policies, and Standard Operating Procedures (SOPs) and sponsor requirements.
The Lead CRA will work in collaboration with Ora's Quality Assurance and Regulatory teams in addition to the external sponsors and sites through all phases of the trial.
**What You'll Do**:
- Independently customize and maintain the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, Project Specific Training Logs.
- Ensure overall project efficiency and adherence to project timelines; report metrics and out-of-scope activities to the CRA line Manager, Sponsors, or Clinical PM's.
- Collaborate with other functional groups within the company such as data management, project management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
- Manage and follow study activities through ongoing tracking and review of study progress.
Provide input and report progress to the assigned clinical project management leaders.
- Conduct review of CRA visit reports within required timeframe, track CRA compliance and proactively escalate quality or non-compliance issues to Monitoring Management.
- Handle escalations for site management questions and issues for assigned projects.
- Develop and deliver presentations & training to clients, colleagues and professionals, as required.
- May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.
- Host routine CRA team calls with a focus on best practice / knowledge sharing.
- Provide Central Data Review and coordinate Risk Based Monitoring strategy, as applicable.
- Supports audit and inspection activities as needed and may assist with on-site CRA training and evaluation upon request.
- Travel Requirements up to 25%.
- Adhere to all aspects of Ora's quality system.
- Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora's values
- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
- Responsibilities may differ from the above based on the specific needs of the business.
**What We Look For**:
- _Experience needed for the Role:_
- Bachelor's degree with 5 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience.
Years of experience may be considered in lieu of education
- Prior team and/or site lead experience
- _Additional Skills & Attributes:_
- Ophthalmic experience strongly preferred.
- Understand how to properly assess an investigative site's capabilities for conducting clinical research.
- Ability to monitor and report on the progress of the trial from start-up to completion.
Knowledge of how to select and qualify an investigative site.
- Strong attention to detail in order to review CRA visit reports.
- Extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits.
- Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Multilingual communication is a plus
- _Competencies and Personal Traits:_
- **What We Do**:
- **Execution Excellence**:Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
- **Ho

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