Website Hektoen Institute LLC
This position will support clinical research under the newly funded R01 grant within the Division of Urology at John H. Stroger, Jr. Hospital of Cook County. The Clinical Research Coordinator (CRC) will be responsible for coordinating and timely handling of all components of clinical research protocols, including pre- and post-research activities, in and outside of the clinical setting. Responsible for the implementation and conduct of multiple research projects of all clinical phases (I-IV). Develop and implement effective patient recruitment strategies. Coordinate comprehensive patient protocol treatment schedules to maintain compliance to protocol requirements. Oversee and participate in subject recruitment, screening, scheduling, testing and data management for multi-faceted investigation. Support Principal Investigators (PI) in other project tasks as assigned. Successful candidates must be fluent in Spanish and be committed to working with diverse populations.
- Assists in establishing and coordinating the implementation of clinical research
- Ascertain eligibility of research subjects per protocol.
- Execute informed consent process and monitor patient status; enroll patients into research studies, explain the studies to the patients and obtain/document proper informed consent.
- Administer standardized surveys and research questionnaires.
- Ensure that participant enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and strictly follow research sponsor guidelines.
- Collect, process & store biological specimens; take vitals and measurements; oversee shipping and receipt of study specimens.
- Review laboratory and clinical procedures and evaluations regularly to ensure protocol compliance.
- Abstract data from medical records and enter data into source documents and protocol specific case report forms (CRFs) and electronic data capture system(s) (EDC).
- Record data on source documents and CRF’s and/or electronic data capture systems (EDCs).
- Conduct QA/QC checking for database validity and data monitoring.
- Assist investigators in preparing study data, literature reviews, analysis for meeting presentations and publications.
- Prepare protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.
- Maintain all study documents (regulatory binders, source documents, correspondence, etc.).
- Maintain inventory of supplies/equipment.
- Monitor/assess adverse events and report them as required.
- Participates in regular investigator meetings.
- Supports medication management and a pharmacologic treatment intervention.
- Performs other related duties and participates in special projects as assigned.
- Bachelor’s degree in nursing, health science, or a health-related field required.
- Spanish fluency (ability to speak and write) required.
- A minimum of 3 years related research experience; genitourinary/oncology experience in all phases of clinical trials is highly desirable.
- Knowledge of medical terminology and procedures including electronic medical records.
- Strong interpersonal, verbal and written communication skills. Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, residents, students, and others in a culturally diverse clinical context.
- Ability to manage multiple tasks and to function independently. Excellent organization and attention to detail required. Ability to handle competing demands with diplomacy and enthusiasm is required.
- Ability to read and understand complex documents required. Ability to absorb large amounts of information quickly.
- Strong computer skills and proficiency in MS Office (word, excel, access) and other related software required. Knowledge of REDCap and experience with various EDCs.
- Demonstrated competence regarding ethics and privacy issues in clinical research.
- Knowledge of research protocols, principles and procedures; knowledge of aspects of clinical trials such as screening, interviewing, case reports forms; knowledge of experimental design, mathematics, statistics, computer applications and computer data management; oral and written communication skills; knowledge of a science such as biology or psychology; ability to identify, produce, organize, evaluate and interpret data; knowledge of ethics and regulatory procedures (i.e. informed consent, IRB applications, data safety and monitoring plans) involved with clinical trials and other clinical research; ability to work as a member of a project team; knowledge of clinical laboratory tasks required for research (e.g. phlebotomy, centrifugation, interviewing).
- CRC and IATA certification preferred; CITI basic HSRP and GCP training required within two weeks of hire date.
- Ability to travel to satellite sites in the Chicago area on a short notice required.