Clinical Research Coordinator 2

University of Chicago•Chicago, IL

1d•Onsite

About The Position

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. The job compiles, documents, analyzes, and reports on moderately complex clinical studies. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University. The Clinical Research Coordinator 2 (CRC2) is a specialized research professional working with and under the direction of the Principal Investigator (PI), Co-investigator(s), and other study personnel to follow the clinical protocol. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the CRC 2 is delegated to perform study related tasks across the life cycle of the study. The CRC2 plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position is housed within the Clinical Research Incubation Unit but will work directly with investigators in the Department of Orthopaedic Surgery. The CRC 2 acts as a key communicator, project manager, and clinical research conduct knowledge partner alongside the investigator, sponsor, and institution to support compliance, financial, personnel and other related aspects of the clinical studies.

Requirements

Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Nice To Haves

Bachelor's degree.
Relevant research experience.
Experience coordinating clinical trials or previous experience coordinating complex clinical trials.
Knowledge of medical terminology/environment.
Strong knowledge of clinical research regulations and best practices.
Excellent time management and ability to prioritize work assignments.
Ability to read and understand clinical trial protocols.
Ability to work collaboratively with professionalism.
Strong interpersonal skills.
Comfort in clinical settings and patient interaction.

Responsibilities

Participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Maintain working knowledge of current protocols, and internal SOPs.
Develop standard work to support efficient workflows.
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
Follow procedures, maintain records, track progress, and respond to data queries in timely manner.
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
Support drafting and review of peer reviewed study publications under supervision of study PI.
Accountable for all tasks in moderately complex clinical studies.
Assists with various professional, organizational, and operational tasks under moderate supervision.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence.
Contributes to the problem solving on assigned clinical research studies and tasks.
Performs other related work as needed.