Clinical Trials Project Coordinator
hace 1 día
About Ora
Ora is a leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research to efficiently bring new products and therapies to market. With 45 years of experience, our expert teams have helped earn more than 85 new product approvals.
The Company Overview:
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. Our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
Job Description: Clinical Trials Project Coordinator
We are seeking an Associate Clinical Project Manager to drive clinical ophthalmic projects forward utilizing best practices to ensure budgets, timelines, and clinical trial requirements are met on behalf of the sponsor. This role will work independently and with oversight as needed to manage cross-functional project teams.
Responsibilities:
- Independently manages cross-functional project teams to deliver high-quality clinical trials in compliance with all regulations and SOPs.
- Works with functional areas to initiate, plan, execute, control, close, and resource clinical trial projects.
- Acts as an operational nexus or focal point for interdepartmental and intradepartmental groups, coordinating these different groups in a matrix environment to drive and complete clinical programs.
- Reviews protocol, source documents, and CRFs and tracks them to completion.
- Covers creating and maintaining project timelines for each project and uses these timelines to track and manage a project's progress.
- Creates Project Plans, with direction from senior leadership Roles and Responsibility Tables and Communication Plans, and weekly project budget and progress reviews for each study.
Requirements:
- A bachelor's degree in a related field such as life sciences, business administration, or health care management.
- Prior experience in clinical research, preferably in a project coordination or management role.
- Knowledge of clinical trial processes and regulations, including GCP, ICH, and EU Directives.
- Excellent communication and organizational skills, with the ability to work effectively in a matrix environment.
What We Offer:
- An estimated salary range of
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