Senior Clinical Research Coordinator

* Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of case report forms, and adverse event reports.
* Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted within the department.
* Assists with or plans and implements the clinical study goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data; processes blood and urine specimens.
* Acts as a liaison with medical staff, University departments, ancillary departments and/or network facilities.
* Collaborates with department administration on research initiatives, strategy development and clinical research oversight.
* Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or acts as a consultant within an area of clinical expertise.
* Supervises junior staff.
* May assist in the training of new or backup coordinators.
* Conducts regulatory work in accordance with requirements for their own studies or those of their team.
* Maintains working knowledge of current protocols, and internal SOPs.
* Accountable for high standards of clinical research practice and assists in the development of accountability in others.
* Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
* Oversees and participates in the coordination and conduct of moderately complex clinical research studies and ensures compliance with federal and institutional regulations.
* Prepares, submits, and assists Investigators with multiple levels of research documentation, i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms.
* Provides investigators with guidance regarding protocol requirements.
* Maintains regulatory documentation.
* Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
* Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
* Attends continuing education and training opportunities relevant to job duties.
* Accountable for all tasks in complex clinical studies.
* Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
* Performs other related work as needed.
*
* Education:

*** Advanced degree in related field.
*
* Experience:

*** Clinical research experience or relevant experience.
* Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).
** Preferred Competencies
*** Strong communication skills (verbal and written).
* Excellent interpersonal skills.
* Adaptability to changing working situations and work assignments.
* Ability to comprehend technical documents.
* Ability to develop and manage interpersonal relationships.
* Ability to exercise absolute discretion regarding confidential matters.
* Ability to follow written and/or verbal instructions.
* Ability to handle sensitive matters with tact and discretion.
* Ability to pay attention to detail.
* Ability to perform multiple tasks simultaneously.
* Excellent time management and ability to prioritize work assignments.
* Ability to train or teach others.
* Working knowledge of Good Clinical Practice (GCP).
** Application Documents
*** Resume/CV (required)
* Cover Letter (preferred)
When applying, the document(s)
** MUST
* * be uploaded via the
** My Experience
** page, in the section titled
** Application Documents
** of the application.

The University of Chicago is an urban research university that has driven new ways of thinking since 1890.

Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.

We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.

To learn more about the university
#J-18808-Ljbffr