- Screening of study participants including chart reviews and assessing medical history and medications
- Conduct of study visits with an emphasis on assessing for, documenting, and managing adverse events
- Timely reporting of adverse event data to study sponsors and Institutional Review Boards (IRBs)
- Data entry into study-specific databases and clinical trial electronic data capture (EDC) systems; Responding to EDC queries
- Instructing and assisting study participants with urine collection
- Study participant and caretaker education on the use of oral study medications
- Updating and maintaining infusion plans
- Assisting CTRC staff with study drug infusions
- Assisting clinicians during lumbar punctures
- Phlebotomy and assisting study coordinators with phlebotomy
- Reviewing laboratory test results
- Contacting study participants after and between study visits (including to follow up on study procedures and assess for adverse events and changes in medication usage)
- Preparation of annual continuing review documentation including adverse event summaries
- Managing study visit supplies (such as lumbar puncture and urinalysis supplies)
- Ensuring integrity and quality of protocol procedures and resultant data
- Contributing toward maintaining regulatory compliance and associated documentation
- Recognition of, documentation of, and communication about protocol deviations within sponsor and institutional guidelines
- Attending, actively participating in, and providing updates at recurring Layton Center Clinical Trials Team meetings
- Ensuring that required Collaborative Institutional Training Initiative (CITI) program trainings are complete, up to date, and renewed in a timely manner
- Additional duties may be assigned based on needs of the Layton Center Clinical Trials Team
- Coordinating with clinic team members to ensure coverage
- Implementing nursing interventions and follow-up care
- Assisting providers and patient families in symptom management and in identifying community resources
- Maintaining comprehensive Epic/MyChart documentation