Clinical Research Support Specialist
1 week ago
Position: Clinical Project Assistant
Location: Remote
Compensation: $47.94/hr
Role Responsibilities:The Clinical Operations team is dedicated to the global execution of clinical trials spanning all phases, ensuring compliance with established protocols, company policies, and regulatory standards. This role is crucial in delivering high-quality clinical data that facilitates the registration and commercialization of innovative products.
As a Clinical Project Assistant, your contributions will include:
- Maintaining and organizing study-specific data utilizing various tools such as databases and spreadsheets.
- Participating in the quality assurance processes for data and documentation.
- Coordinating meeting logistics, including agenda preparation and minute-taking.
- Collaborating with cross-functional teams to ensure the successful completion of assigned tasks.
- Assisting in the creation of essential documents and standardized forms.
- Ensuring compliance with established practices, policies, and regulatory requirements.
- Engaging with teams across Oncology, Inflammation, and Virology therapeutic areas.
- Supporting sample reconciliation efforts for ongoing clinical studies in partnership with study leads.
- Utilizing eTMF/Veeva systems for documentation management.
- Participating in presentations as required.
- Advanced degree (MA/MS/PharmD/PhD) with relevant clinical or life sciences experience.
- Bachelor's degree (BA/BS) or RN with a minimum of one year of clinical experience.
- Familiarity with FDA, EMA regulations, ICH guidelines, and GCP.
- Proficient in Microsoft Word, PowerPoint, and Excel.
- Strong verbal, written, and interpersonal communication skills.
The Fountain Group is a leading staffing firm with a diverse portfolio of clients, including over 80 Fortune companies. Established in 2001, we pride ourselves on our commitment to excellence, consistently recognized through various industry awards. Our success is built on teamwork and collaboration.
For more information about our company and the services we offer, please visit our website.
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