Clinical Monitoring Professional
3 giorni fa
Job Summary:
We are seeking an experienced Lead Clinical Research Associate to join our team at Ora. In this role, you will be responsible for developing strong clinical site relationships and ensuring compliance with study conduct.
Key Responsibilities:
- Customize and maintain the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, and Project Specific Training Logs.
- Ensure overall project efficiency and adherence to project timelines, reporting metrics and out-of-scope activities to the CRA line Manager, Sponsors, or Clinical PMs.
- Collaborate with other functional groups to support milestone achievement and to manage study issues and obstacles.
- Manage and follow study activities through ongoing tracking and review of study progress, providing input and reporting progress to clinical project management leaders.
- Conduct reviews of CRA visit reports within required timeframes, tracking CRA compliance and proactively escalating quality or non-compliance issues to Monitoring Management.
- Handle escalations for site management questions and issues for assigned projects.
- Develop and deliver presentations and training to clients, colleagues, and professionals, as required.
- May be assigned additional responsibilities 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 and data integrity & business ethics and regulatory requirements.
- Clear and sustained demonstration of Ora's values – prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.
Requirements:
- Bachelor's degree with 5 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experience.
- Prior team and/or site lead experience.
- Ophthalmic experience strongly preferred.
What We Offer:
- Competitive salaries along with a structured pension plan.
- Private medical insurance healthcare from day one.
- Company-paid life and disability insurance.
- 25 days of annual leave plus birthday PTO and bank holidays.
- Remote and wellness reimbursement.
- Continued opportunities to grow and develop your career journey.
- Opportunities to work with colleagues across the globe.
- A chance to research new ophthalmic therapies that will impact patients across the globe.
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