The University of Chicago's Duchossois Family Institute (DFI) is looking to solve the problem of optimizing microbiome-mediated host defenses to enhance human health by developing new knowledge about the interactions between the human body and the microbiome.
Requirements
- Experience with FDA regulated clinical trials and investigator initiated clinical trial site management
- Credentialing as a Certified Clinical Research Professional (CCRP) or Registered Nurse (RN) license
- Advanced knowledge in regulatory affairs and reporting requirements
- Direct experience preparing and submitting FDA regulatory documents and responding to agency queries
- Advanced proficiency in regulatory reporting, audits, monitoring, and compliance
- Proficient in clinical data management systems (EPIC, REDCap, or equivalent); experience developing and implementing data collection tools and quality assurance measures
- Proficient in mentoring, training and managing staff, projects and clinical trials
Responsibilities
- Manages day-to-day clinical research study operations for research staff and principal investigators (PIs)
- Supports clinical trial initiation and ensures milestones are met throughout study lifecycle
- Manages recruitment and enrollments efforts for multiple clinical studies and trials
- Conducts and documents informed consent procedures for clinical studies, ensuring participant understanding and regulatory compliance
- Tracks and reports key metrics, including adverse events and protocol deviations, to compliance committees
- Develops and maintains complex research study databases, collaborating closely with institutional data teams to ensure data integrity and security
- Demonstrates advanced proficiency in clinical study monitoring and auditing; leads and trains others in all aspects of quality assurance activities
Other
- Minimum requirements include a college or university degree in related field
- Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline
- Strong leadership, staff development, team management and mentoring skills
- Effective communication, stakeholder engagement and collaboration skills
- Excellent organizational and detailed documentation practices
