Website Hektoen Institute LLC
Provides clinical and research expertise to Infectious Disease Clinical Trials in both in the Stroger Hospital inpatient setting and the CORE Center outpatient clinical setting, studies include COVID-19 trials and HIV/STI treatment and prevention trials. Current study of priority is an NIH funded adaptive platform trial for accelerated testing and selection of promising therapeutic agents for the treatment of COVID-19. This study will enroll participants hospitalized for moderate to severe COVID-19 infections and following them for 29 days post study treatment.
Takes direction from and work is overseen by the study Principal Investigator. Will be responsible for inpatient study visits at Stroger Hospital, and outpatient visits post discharge at the CORE Center. Study visit tasks will include but not be limited to consenting, specimen collection (nasopharyngeal and oropharyngeal swabs and blood), and the collection of vital signs and other study related health indictors. All collections must be conducted according to NIH procedures and documented per study protocol.
Future studies may include trials to develop more effective prevention and treatment approaches to control sexually transmitted infections (STIs) and HIV in the outpatient clinical setting of the CORE Center.
Given the changing landscape of COVID-19 and Infectious Disease treatment and care, the ideal applicant will be flexible, and able to quickly learn and adapt to new study protocols and procedures. Occasional weekend availability may be required.
Clinical and Research Practice:
- Maintains a thorough working knowledge of protocol schemas and requirements
- Collaborates with physicians to maintain strict protocol adherence and serves as a protocol resource for medical providers.
- Monitors clinical status of patients; interprets and acts on results of laboratory tests and procedures; monitors adverse effects of study drugs.
- Actively screens potential study participants for trial eligibility; arrange and conduct all patient visits, inpatient and outpatient, as specified by the study protocol.
- Obtains informed consent from eligible subjects.
- Ensures adherence to protocol requirements.
- Conducts the research study, and monitors and reviews case reports forms as necessary.
- Ensures availability of research protocol supplies and resources; order as necessary.
- Maintains system to provide patient compensation
- Attends all scheduled conference calls/meetings.
- Works with pharmacist to assure study medication is available and dispensed on schedule.
- Collects all study specimens (phlebotomy) and work with study coordinator to assure processed and shipped per protocol
- Attends investigator meetings and study initiation meetings
Data Quality/Quality Assurance Activities:
- Collects research/clinical trial specific data and ensures accurate data entry and quality improvement data.
- Maintain source documentation.
- Complete case report forms after each study visit in a timely manner—per funders guidelines.
- Lead study monitoring visits, responds to monitor’s concerns/comments
- Conduct data entry as required by each study and responds to delinquency reports and queries; assure all AEs and SAEs are reported in accordance with funders guidelines
Ensure subject medical care:
- Educate patients regarding study protocols; monitor patient progress and changes in status throughout course of study.
- Perform all nursing related protocol duties.
- Monitor patient compliance with specific protocol; provide instruction and counsel as needed.
- Ability to perform venipuncture stick for blood collection per protocol.
- Monitor any side effects and toxicities and report to PI/physician.
- Deliver primary nursing care in conjunction with the client’s primary care team.
Appropriate Handling of Hazardous Material
- Comply with site policies concerning biohazardous materials, as well as health, safety, and hazardous waste regulations
- Abide by laboratory safety procedures
- BSN or RN required, licensed in Illinois.
- Bilingual spoken and written skills in English and Spanish required- must be able to communicate without translation services
- Willingness to work closely with COVID infected patients required
- 2 year’s experience in research preferred.
- 1 year experience working in hospital in patient setting preferred
- Computer literate; experience with electronic data entry system.
- Knowledge and experience in clinical care of clients.
Sensitivity to the cultural diversity of clients served by John H. Stroger, Jr. Hospital of Cook County/CORE Center