Senior Clinical Research Coordinator

Department

BSD NEU - Clinical Research Staff

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.

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.

• 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 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.

• Advanced degree in related field.

• Clinical research experience or relevant experience.
• Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

• Strong communication skills (verbal and written).
• Excellent interpersonal skills.
• Adaptabilit…