What are the responsibilities and job description for the Clinical Project Coordinator position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description
Responsibilities :
- 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.
- This position is eligible for remote employment within the United States and requires travel up to 5% of the time.
- 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.
Requirements :
