Clinical Operations Project Coordinator II
1 week ago
Position Overview:
We are seeking a dedicated Clinical Project Assistant II to contribute to our expanding Clinical Operations team at Net2Source Inc. This role is pivotal in the execution of clinical trials across various therapeutic areas, ensuring compliance with established protocols and regulatory standards.
Key Responsibilities:
- Assist in the initiation, management, and closure of clinical studies.
- Compile and maintain study-specific information utilizing various tools such as databases and spreadsheets.
- Engage in quality assurance processes for data and documentation.
- Coordinate meeting logistics, including agendas and minutes.
- Collaborate with cross-functional teams to fulfill project requirements.
- Support the development of essential documents and standard operating procedures.
- Ensure adherence to established practices and regulatory requirements.
- Facilitate sample reconciliation for ongoing clinical studies in partnership with study leads.
- Utilize eTMF/Veeva systems for document management and filing.
- Participate in presentations as necessary.
Qualifications:
The ideal candidate will possess a unique blend of skills and experiences:
- Advanced degree (MA/MS/PharmD/PhD) with relevant clinical experience or a bachelor's degree (BA/BS/RN) with a minimum of one year of related work experience.
- Familiarity with clinical operations and business processes is advantageous.
- Proficient in Microsoft Office Suite, including Word, PowerPoint, and Excel.
- Exceptional verbal and written communication skills.
Additional Skills:
- Ability to quickly adapt and learn in a dynamic environment.
- Strong teamwork and collaboration skills.
- Good analytical and organizational capabilities.
- Understanding of FDA, EMA regulations, ICH guidelines, and GCP is preferred.
- Clear and concise communication abilities.
- Willingness to travel when necessary.
We value diverse contributions and are committed to supporting our patients through innovative clinical solutions.
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