As the fiscal agent for the Cook County Health and Hospitals System (CCHHS) Family Planning Program, Hektoen Institute of Medicine’s mission is to improve the care of the sick by supporting programs that enhance patient care and extend the boundaries of knowledge through education and research. The Clinical Research Nurse would work within CCHHS, whose mission is to serve as the primary provider and facilitator of healthcare for the underserved: Medicaid patients, low-income Medicare recipients and the uninsured. The CCHHS is the safety net for health care in Chicago and suburban Cook County.
- Becomes familiar with all protocols assigned. For assigned studies, initiates study start-up activities including study initiation meeting, scheduling subject visits, along with scheduling any outside personnel or tests for these individual visits.
- Evaluates volunteer subjects for potential study qualification in accordance with inclusion/exclusion criteria provided by study sponsor. Assists in subject recruitment as well as acting as a resource for the marketing personnel and referring physicians.
- For qualified participants, initiates medical and social histories, physical exam, and physiological measures as indicated in protocol. Records this data in detail. Schedules study visits as required by protocols.
- Ensures appropriate laboratory, x-ray and other diagnostic examinations are scheduled and completed per study protocol. Oversees any outside services as required.
- Reviews medical, laboratory, and other diagnostic data on study subjects. Notifies principal investigator of any abnormal values or any significant changes in these values. Notifies and follows up with subjects as required.
- Reports serious adverse events to principal investigator and sponsor in a timely manner. Follows up with subjects or subject family members in accordance with requirements.
- Collects data requested by protocol. Ensures accuracy of data obtained. Collates and enters data into subject charts, sponsor case report forms, and/or remote data entry equipment in a timely and precise manner.
- Ensures that all study drug received in unit is accurately documented and stored in locked location. Ensures that study drug is maintained in appropriate temperature controlled environment. Verifies that all study drugs is correctly labeled, and packaged. Ensures that appropriate study drug is dispensed to subject along with detailed instructions on use. Maintains accurate documentation of study drug receipt/dispensation.
- When studies require other supplies and/or equipment, coordinator will ensure their availability and ensure proper orientation has occurred prior to use.
- Ensures subject compliance with study drug and study visits. Documents all efforts made to retrieve study medication. Notifies sponsor of any deviations from protocol. Whenever possible, obtains exceptions.
- Schedules routine study reviews with sponsor monitors or appointed sponsor representative. Arranges access to all subject records for the indicated time period of review. Allows time to respond to monitor questions and to make correction to case report forms. Promptly responds to sponsor queries.
- Prepares for and completes close out procedures for terminated studies. Ensures all FDA, sponsor, and center regulations have been followed.
- Provides health practices information and education to practice and study subjects regarding medications, diseases, diet, exercise, and any special procedures. Assists patients by providing appropriate referrals to physicians, clinics, or agencies.
- Acts as a liaison for subject/physician telephone calls.
- Assist with training of other research personnel.
- Works with other clinical research associates/assistants to provide back-up replacement during absences, and follow-up as needed.
- Actively participates in clinical meetings, rounds, and departmental meetings.
- Participates in other activities such as special projects, and any other duties as assigned by supervisor.
- Provides research manager weekly updates on study recruitment, enrollment, issues, etc.
- Performs other duties as assigned.