Clinical Research Assistant

Department BSD OCR - Clinical Research Incubation About the Department The Office of Clinical Research (OCR) is the nucleus of the clinical research enterprise, providing services, training, tools and compliance oversight to support the conduct of clinical research across the entire Biological Sciences Division and University of Chicago Medicine human subject research portfolio. The mission of the Office of Clinical Research is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.

Together, we elevate the human experience with knowledge and health care.

Job Summary The job provides technical research support activities related to collecting, documenting, and reporting on basic clinical studies. Supports the administrative and operational tasks for clinical research conducted across the University. The Clinical Research Assistant is part of the Research Incubation Unit of the Office of Clinical Research. The Clinical Research Assistant (RA) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI).

While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical research projects, the RA oversees, facilitates and coordinates the daily activities of clinical research and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position is housed within the Research Incubation Unit but will work specifically with investigators in the Orthopaedic Surgery Department.

By performing these duties, the RA works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies. This position will have primary accountability to the Clinical Research Manager for the Department of Orthopaedic Surgery within the Office of Clinical Research. This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract.

Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance. Responsibilities
* Research tasks include recruitment, screening for eligibility, consenting participants, conducting research assessments, data entry, and subject follow-up and scheduling.
* Perform specific protocol procedures (specimens and data management, survey/questionnaire administration and the like) required to conduct the study and retain research subjects. Understands protocols and may collect information about adverse events (AEs), identified in the protocol or investigator brochure.
* Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
* May perform data abstraction and entry for retrospective chart review studies.
* Meets with the study PI on a regular basis to discuss study updates.
* Performs all tasks in basic clinical studies.
* Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
* Acquires and applies knowledge of clinical studies to collect analyzable clinical research data and/or samples.
* Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

Certifications:

* -
- Preferred Qualifications

Education:

* Bachelor's degree.

Experience:

* 2 years of work or volunteer experience in a health care related setting. Preferred Competencies
* Strong…