Clinical Trials Research Assistant - Pediatric Nephrology

Within the Stead Family Department of Pediatrics, Division of Nephrology, this position will provide support for Pediatric Nephrology Clinical Research by conducting study visits, collecting and analyzing results and performing operational duties associated with human research.

This is a specified term position.

Duties to include:

• Perform research activities in a specialized area.
• Consult with principal investigator to design forms to facilitate the collection and tracking of participant data, study drugs and study procedures. Design study source documents, assessment tools, and participant questionnaires.
• Meet with families to introduce them to research opportunities currently available. Screen, recruit, enroll and obtain informed consent from research subjects for clinical trials. Responsible for subject recruitment, subject management, scheduling, phone calls, etc. to aid in coordination of study visits.
• Perform procedures and techniques as outlined in clinical research protocols, assure fidelity to protocols. 
• Document all study data in participant source documents and transfer this data to electronic case report forms.  Ensure study data are valid and reliable. 
• Submit protocols to the IRB and other review committees for approval prior to implementing research, as necessary for modifications and then annually for continuing review approvals.  
• Responsible for safety programs by following guidelines and maintaining required documentation. Document all participant Serious Adverse Events and Adverse Events and report these to the primary investigator, study sponsor, and IRB.
• Monitor implementation of study per protocol and ensure procedures are conducted using good clinical practice standards and meeting IRB guidelines.
• Collaborate with Study Sponsors and Coordinating Centers to manage protocols. Meet with study monitors as requested.
• Attend local and national research meetings as required. Present results, findings or updates.
• Attend local fundraising events and activities to market and recruit participants for research studies.  
• Participate in managing the student research staff (if applicable) to assure task completion and compliance with UI policies and procedures. Provide direction, assignments, feedback, coaching and counseling to assure outcomes are achieved. Provide training and oversight on basic lab requirements and protocols.