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| Assistant Clinical Scientist PA Open (J#45808) Title: Assistant Clinical Scientist Company: Inovio Pharmaceuticals Description Responsibilities: - To be responsible for overall clinical study conduct to fully ensure patient safety, verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. - Duties may include oversight of clinical trial operations as performed by a CRO or other external consultants. - Develops and manages clinical protocols and amendments, informed consent forms, training material, case report forms, diary cards, clinical study reports and other clinical documents, and contributes to the development of investigator's brochures. Ensures compliance with regulatory guidelines in the development of documentation. - Oversees study conduct and communicates study-related information to investigators and study staff. - Oversees and tracks recruitment and retention of study subjects. - Manages study timelines. - Reports on study progress and provides options for handling problems that develop. - Provides progress updates and summaries to management. Develop tools and processes that increase efficiencies of the project. - Prepares regulatory documents for FDA and other regulatory submissions. Supports management with implementation of departmental strategies and policies. Travel: Up to 20%, primarily domestic RequirementsQualifications & Requirements: - Required education: Bachelor/Masters degree - Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred. - Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines. - At least 6 years of clinical research experience in Phase 1 and 2. Regulatory affairs experience a plus. - Thorough knowledge of all applicable regulations, including FDA, ICH and ISO guidelines. Medical device experience a plus. | |||
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