SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Clinical Project Coordinator to join the Research and Development team in Corvallis, Oregon. This role provides day-to-day project management support to the clinical research department including support of the Research Assistant and organizing projects related to SIGA's clinical research activities. The Clinical Project Coordinator also provides cross-functional support to internal R&D teams. Reporting to the Director, Clinical Development, the Coordinator is eligible for SIGA's full benefits package including company paid medical, dental, and vision benefits, short and long-term disability, life and AD&D insurance and paid time off. This position is eligible for remote employment within the United States and requires travel up to 5% of the time.

Responsibilities for this position include:

Clinical Trial Coordination

• Primary contact with Contract Research Organizations (CROs) to ensure trials are conducted according to the protocol and study agreements. Ensure the trial is progressing according to ICH-GCP, all applicable regulations and SOPs, contract requirements, and quality standards.
• Develop and maintain recordkeeping systems and procedures and ensure data is collected and processed accurately.
• Track project funding, monitor expenditures, and oversees invoicing and payments as required.
• As required, participate in co-monitoring visits and quality assurance audits at vendors or clinical sites.
• Participate in site visits, audits or inspections from funding or regulatory agencies, as required.
• Review all study documents. Coordinate comments received from various sources and ensure proper incorporation or resolution of all comments.
• Review study data listings, tables, listings and figures and clinical study reports.

Clinical Development Operations

• Provide strategic input on all aspects of the clinical development program.
• Assist with project planning, including developing research designs, data collection methods, and research protocols.
• Evaluate project progress by maintaining timelines and other tracking/analysis tools. Produce and distribute status, resourcing and tracking reports to appropriate team members and senior management.
• Oversee the coordination and management of research projects, including multi-disciplinary teams, research initiatives, and new opportunities.
• Serve as a liaison between research stakeholders, including consultants, departments, and key opinion leaders.
• Maintain communication with the internal and external project team representatives and prepare project status reports, as required.
• Independently prepare information for internal and external meetings. Present prepared information at project review meetings
• Other duties as assigned.

Minimum Qualifications include:

• Bachelor's Degree in a relevant field with at least one year of relevant clinical trials experience within a clinic/hospital, pharmaceutical company, or clinical research organization.
• Demonstrated experience with MS Office Suite with a strong proficiency in MS Excel and Word required.
• Experience as a clinical trial assistant, clinical trial monitor, or relevant role a plus.
• Experience with global public health agencies or organizations a plus.

The successful candidate will possess the following knowledge and abilities:

• Demonstrated success managing projects and timelines and collaborating successfully with others inside and outside of the organization.
• Excellent communication skills, including being comfortable communicating with all levels of stakeholders, from senior leaders to junior staff.
• Is a team player who can work flexibly and enthusiastically within a small business environment.
• Demonstrated success in effectively prioritizing multiple tasks with a high level of accuracy and attention to detail while maintaining a high degree of confidentiality.
• Resourceful, creative, enthusiastic, and results-oriented approach to project management function.
• Excellent analytical and presentation skills