​​Senior Clinical Research Coordinator​​ 2

University of Chicago • Chicago, IL

3d • $75,000 - $90,000

About The Position

In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles. The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high-level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research. The Senior Clinical Research Coordinator 2 will provide support to the Section of Allergy/Immunology and Pediatric Pulmonology. The Sr CRC 2 will be involved in multiple research trial types: investigator initiated, multi-centered cooperative group studies, and multi-centered trials designed, implemented and coordinated in the Section. The Senior Clinical Research Coordinator 2 is a specialized researcher partnering with the Principal Investigator (PI) and under the direction of a departmental research director. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr CRC 2 supports, facilitates and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study. The Sr CRC 2 also oversees other clinical research coordinators and student workers within the Pediatric Clinical Trials Office and the Section. By performing these duties with limited supervision and/or guidance, the Sr CRC 2 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 study. This at-will position is wholly funded by extramural funds (e.g., grant, gift, endowment) which are renewed under provisions set by the grantor of the funds. Employment will be contingent upon the continued receipt of these funds and satisfactory job performance.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Nice To Haves

• Bachelor’s degree .
• 5 years of clinical research experience coordinating multiple and variety of studies, such as investigator initiated; industry sponsored; multi-site trials.
• Overseeing staff.
• Read and understand clinical trials protocols.
• Familiarity with medical terminology/environment.
• Working knowledge of good clinical practices (GCP).
• Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
• Comprehend technical documents.
• Understanding of the federal research regulations and identify the federal research organizations’ role in regulating human research participation.
• Train junior CRCs; train or teach others.
• Participate in protocol review and clinical trials evaluations.
• Excellent interpersonal skills.
• Strong data management skills and attention to detail.
• Handle competing demands with diplomacy and enthusiasm.
• Work collaboratively with faculty and divisional clinical research infrastructure.
• Excellent time management and prioritize work assignments.
• Communicate in writing.
• Communicate orally.
• Develop and manage interpersonal relationships.
• Exercise absolute discretion regarding confidential matters.
• Follow written and/or verbal instructions.
• Give directions.
• Handle sensitive matters with tact and discretion.
• Handle stressful situations.
• Learn and develop skills.
• Maintain a high level of alertness.
• Pay attention to detail.
• Perform multiple tasks simultaneously.
• Prioritize work and meet deadlines.
• React effectively, quickly, calmly, and rationally during conflicts and emergencies.
• Work effectively and collegially with little supervision or as member of a team.
• Work independently.

Responsibilities

• Manages high complexity clinical studies and owns administrative tasks.
• Assists with strategic planning for the research department.
• Trains lower-level roles.
• Studies have high complexity with limited oversight.
• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
• Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.
• 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 complex clinical research studies and ensures compliance with federal and institutional regulations.
• Prepares, submits, and assists investigators with multiple levels of research documentation, such as 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.
• Provides direct supervision of other clinical research staff, such as hiring/firing, performance evaluations, disciplinary actions, approve time off, etc., or assistance.
• Attends continuing education and training opportunities relevant to job duties.
• Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
• Prepares program conference lists for multidisciplinary conferences and workshops.
• Participates in all pharmaceutical site visits.
• Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
• Solves a range of complex problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
• 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.
• Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
• Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
• Performs other related work as needed.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees