Department
BSD NEU - Clinical Research Staff
About The Department
The Department of Neurology at The University of Chicago Medical Center has a great history and tradition, having made significant contributions to neurological training, clinical care, and the basic understanding of neurological disease.
Job Summary
The Senior Clinical Research Coordinator is an onsite, patient-facing, specialized researcher partnering with the clinical Principal Investigators (PI) and under the direction of the Clinical Research Manager. The position oversees, facilitates and coordinates the daily activities of complex clinical research studies and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. They will directly manage a subset of clinical research staff members and provide guidance and mentorship to junior team members, including support with trial start up and regulatory needs.
Responsibilities
* 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
Minimum Qualifications
Minimum requirements include a college or university degree in related field.
Work Experience
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
Certifications
Preferred Qualifications
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.
Job Details
* Job Family: Research
* Role Impact: Individual Contributor
* Scheduled Weekly Hours: 40
* Drug Test Required: Yes
* Health Screen Required: Yes
* Motor Vehicle Record Inquiry Required: No
* Pay Rate Type: Salary
* FLSA Status: Exempt
* Pay Range: $70,000.00 - $85,000.00
The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits
Benefits Eligible: Yes. The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University\'s Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history. The University of Chicago\'s Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
#J-18808-Ljbffr