The position will support ongoing and new clinical research studies for the division of Neonatology in the UI Stead Family Department of Pediatrics.

Duties to include:

Research/Clinical Activities (including subject recruitment and enrollment):

1. Perform skilled clinical/healthcare research activities in the neonatal intensive care unit (NICU).

2. Screen patients for study eligibility and consent for clinical trials.

3. Perform and monitor randomizations into studies.

4. Educate patient families on scope of study, potential risks and benefits, possible alternatives, and study requirements.

5. Perform protocol-driven procedures.

6. Supervise ordering of study medication, schedule study medication, monitor adherence to administration per protocol and identify adverse reactions (as protocol requires).

7. Oversee the recruitment of subjects and scheduling of trial-related procedures.

8. Prepare study recruitment materials.

9. Relay study information to principal investigator.

10. Obtain and process human blood and tissue samples.

11. Counsel the participant and family regarding the intent of the studies.

Protocol Development and Study Responsibilities:

1. Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.

2. Assist clinicians and patient families with problems related to protocol.

3. Oversee case report form development. Review query reports. Resolve monitoring visit issues.

4. Develop complex study materials.

5. Serve as liaison to local healthcare practitioners, agencies and sponsors.

6. Serve as a member of the interdisciplinary clinical research team, working closely with the Research Manager to plan, develop and implement research protocols.

7. Attend protocol meetings as required (may be overnight travel). Possess a thorough understanding of the protocols.

Data Collection and Monitoring:

1. Participate in the design, development and testing of clinical research trial data management systems.

2. Validate data and make recommendations for resolution.

3. Revise and implement changes in data collection.

4. Responsible for collecting, assembling and mailing data forms, bills, specimens and other protocol-related documents and medical records.

Regulatory Guidelines and Documents:

1. Manage and organize regulatory documentation. Prepare regulatory (IRB, etc) submissions.

2. Perform on-site audits of research and clinical data.

3. Maintain regulatory binders/folders for each protocol.

4. Recommend corrective action for reportable events.

5. Communicate with Research Manager and PI about the status of the research projects.

6. Follow federal regulations related to human subjects’ research.

7. Monitor compliance of regulatory guidelines and proper maintenance of documents. Follow universal precautions and general policies and procedures in accordance with university, collegiate, hospital and federal guidelines.

Human Resources/Leadership:

1. Instruct other staff regarding clinical research and methods employed in research studies as appropriate.

2. Maintain effective working relationships with faculty, staff, students and the public.

3. Mentor new staff under direction.

Financial Responsibility:

1. Assist in budget development and management of resources/supplies for studies.

2. Contribute to identification of increased cost/inefficient spending and cost containment measures.

3. Assist participants with questions related to billing for protocol treatment procedures.