Senior Clinical Research Coordinator
The University of Chicago

Department

BSD MED - Cardiology - Clinical Research Staff

About the Department

The Section of Cardiology was founded in 1950 and has a proud history. We are now charting a new course that will propel us to the forefront of cardiovascular medicine. The strength of the Section reflects the quality and dedication of its faculty, trainees and support staff and is enhanced by the rich environment at the University of Chicago.

Job Summary

The Senior Clinical Research Coordinator (Sr CRC) is an onsite, patient-facing, specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager in the Section of Cardiology in the Department of Medicine.

While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr CRC supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the Sr CRC 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.

Responsibilities

• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of case report forms, and adverse event reports.
  
• Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
  
• Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
  
• Identifies and explains the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
  
• Coordinates the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence and data integrity.
  
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
  
• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
  
• Performs assessments at visits and monitors for adverse events.
  
• Organizes and attends site visits from sponsors and other relevant study meetings.
  
• Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
  
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
  
• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
  
• Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
  
• Ensures compliance with federal regulations and institutional policies.
  
• May prepare and maintain protocol submissions and revisions.
  
• May assist in the training of new or backup coordinators.
  
• Ability and willingness to cross-cover cardiology coordinator peers when needed.
  
• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
  
• 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.
  

Minimum Qualifications

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

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Preferred Qualifications

Education:

• Advanced degree.
  

Experience:

• Data entry and management.
  
• Human specimen processing and shipping.
  
• Working knowledge coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).
  

Licenses and Certifications:

• Research certification (e.g., Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP).
  

Preferred Competencies

• Develop a program and a team.
  
• Excellent time management skills and ability to work independently.
  
• Develop research program and work strategically with Principal Investigator(s).
  
• Lead robust operational and financial analysis of study(ies) and/or program performance.
  
• Read and understand clinical trials protocols.
  
• Knowledge of regulatory policies and procedures.
  
• Strong analytical skills.
  
• Knowledge of grant and contract administration.
  
• Familiarity with medical and scientific terminology.
  
• Demonstrated knowledge of Good Clinical Practices (GCP).
  
• Identify funding sources.
  

Application Documents

• Resume/CV (required)
  
• Cover Letter (required)
  

When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Research

Role Impact

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

40

Benefits Eligible

Yes

Drug Test Required

Yes

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.

Staff 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.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

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