The Study Implementation Coordinator position will provide and manage support for clinical trial start-up for the Immunology Program. The incumbent will be responsible for assessing the operational logistics of new clinical trials and implementating start-up plans to address review requirements and operational needs. The position will develop billing grids and budgets for program clinical trials, complete start-up implementation materials for multi-Institutional protocol implementation reviews. This position requires understanding of the research process and the resources required to conduct clinic research, as well as clinical trial billing guidelines and practices.
This is an exciting opportunity to be involved in the early stages of structuring study start up for immunotherapy trials.
- Review and assess new clinical trials to identify operational, regulatory and resource requirements.
- Create start-up plans and implement resources to complete start-up tasks to support billing, operations and protocol implementation for all protocol practice sites.
- Maintain direct communication with Program faculty, clinic departments, funding sponsors, and research collaborators in support of the overall research plan; report start-up progress to PIs and study staff ensuring transparency during the process and identifying any issues.
- Ensure all practice site requirements are met to activate clinical trials within defined timelines.
- Prepare patient and staff education materials, CPOE PowerPlans, patient calendar templates and other materials to assist with study management.
- Collaborate with protocol PI, study staff and database support staff to develop data capture plan and tools.
- Provide assistance with relevant regulatory submissions as requested.
Experience and Abilities
- 3-5 years starting and managing clinical trials, preferably oncology trials
- Preparing study startup documents (i.e. SCCA/ ITHS /SC applications, case report forms)
- Working with multi-disciplinary teams
- Preparing clinical trials budgets and billing practices
- Familiarity with good clinical practice and oncology standards of care preferred
- Forecasting and meeting deadlines
Knowledge and Skills
- Bachelor's Degree
- Clinical research related certification preferred
- Familiarity with project management tools and techniques
- Strong verbal and written communication skills
We are a VEVRAA Federal Employee.