Iowa State University
Description
Support, conduct and manage clinical trials to deliver and evaluate research protocols in patients living with HIV in the UIHC Virology Clinic under the Ryan White Program. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines and documents; human resources/leadership; and financial responsibility.
Key Responsibilities
Protocol Development/ Management and Study Responsibilities
- Assist in the design, development, execution, administration and maintenance of Virology Clinic protocols and clinical studies.
- Assist in study design and protocol development and provide input into descriptions of complex research procedures.
- Oversee CRF development.
- Review query reports and participate in Quality Management Group.
- Resolve all monitoring visit issues.
- Perform and monitor randomizations.
- Develop complex study materials.
- Serve as liaison to local health care practitioners, agencies and sponsors.
Research/Clinical Activities; Subject Recruitment and Enrollment
- Screen, recruit, enroll and obtain informed consent for clinical trials.
- Oversee the recruitment of subjects and scheduling of trial-related procedures.
- Educate study participants on scope of study, potential risks and benefits, possible alternatives and study requirements for participants.
- Relay information to principal investigator and verify student participant eligibility.
Data Collection and Monitoring
- Participate in the design, development and testing of clinical research trails data systems.
- Validate data, query resolution and make recommendations for resolution.
- Revise and implement change in data collection.
Regulatory Guidelines and Documents
- Manage and organize regulatory documentation from sites and regulatory authorities.
- Prepare regulatory submissions.
- Perform on-site audits or research and clinical data.
- Monitor compliance of regulatory guidelines and proper maintenance of documents.
- May recommend corrective action for reportable events.
Human Resources/Leadership
- May provide functional and/or administrative supervision.
- Mentor new staff under direction.
Required Qualifications
- A Bachelor's degree or an equivalent combination of education and experience is required.
- Excellent written and verbal communication are required.
- 1-3 years of related experience is required.