The job includes but is not limited to: screening patients for study eligibility, scheduling research visits/follow up, tracking/auditing consent forms and study related documents, preparation for both internal and external audits, collecting data and submitting to appropriate organizations, processing/packaging of lab specimens, maintaining inventory of research supplies, creating electronic research charts, scheduling site monitor visits and meeting rooms as needed and assisting in the implementation of new laboratory protocols and processes. .

This is a fast- paced working environment involving time sensitive specimens and hard deadlines for data submissions. A high level of organization with attention to detail and the ability to manage multiple responsibilities is required.

This position will work with multiple departments and must maintain a high level of professionalism and a continuous process improvement mindset.

The Clinical Research Assistant will be required to complete Human Subjects Protection (HSP) training, CITI training (including Good Clinical Practice (GCP), as well as become a member of the Children's Oncology Group (COG) research base.

Required skills include ability to work with children, experience with computer data entry and statistical analyses, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE.

1. Follows all aspects of Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting and following up on Serious Adverse Events.
2. Coordinates the collection, processing, storage and/or shipping of clinical research specimens. Will be required to complete appropriate course to ensure compliance with the handling/shipping of specimens.
3. Attends patient planning meetings, huddles, and webinars as assigned.
4. Screens patients for study eligibility by attending meetings and utilizing the electronic health record EPIC.
5. Develops strategies to ensure study subject compliance with protocol requirements.
6. Coordinates protocol activities; prepares clinical specimens for shipment to central laboratories and obtains results as needed.
7. Performs clinical data gathering and measurements; maintains various databases to ensure accurate data is readily available.
8. Assists in data analysis.
9. Additional miscellaneous duties and responsibilities, as may be assigned from time to time by employee's supervisor.