Senior clinical research scientist vs senior clinical research associate

Differences between senior clinical research scientist and senior clinical research associate duties and responsibilities

Senior clinical research scientist example responsibilities.

• Supervise and manage planning, implementation, conduct and reporting of assign early phase international clinical studies in oncology.
• Contribute to the development of templates for protocols and clinical study reports following FDA, GCP and ICH guidelines.
• Authore and review abstracts, manuscripts, slide decks and posters in collaboration with internal and external (CRO) stakeholders.
• Lead feasibility and identification of CRO selection for pediatric program.
• Recruit investigators perform pre-study visits, negotiate budgets, initiate and monitor studies and verify data for accuracy and completeness.
• Manage clinical monitors in successful completion of large international hypertension study.

Senior clinical research associate example responsibilities.

• Manage a consultant to review scientific support and create dossiers on each product that make health claims in the EU.
• Interact with FDA and other regulatory authorities to manage and facilitate approval of regulatory submissions.
• Monitor U.S. sites in accordance with ICH and GCP guidelines.
• Maintain investigators and subjects files, review investigators files for compliance with GCP and FDA regulations, review drug utilization records.
• Verify informed consent procedures and protocol requirements base on applicable regulatory requirements to ensure protection of study patients.
• Provide site management for both therapeutic and supportive care oncology protocols that are complex and require knowledge in advance therapeutic areas.
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