Chicago, IL, USA
98 days ago
Senior Clinical Research Coordinator

Department
 

BSD CCC - Network Oncology Research


About the Department
 

The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 190 faculty members from twenty departments with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.


Job Summary
 

The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the Sr CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations.

The Sr CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. By performing these duties, 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 studies.

This position independently manages the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

Responsibilities

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.Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or acts as a consultant within area of clinical expertise.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 conductsquality 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, 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.Provides direct supervision of other CRC staff, including but not limited to, hiring/firing, performance evaluations, disciplinary actions, manage time off, etc. Attends continuing education and training opportunities relevant to job duties. Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.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:

Bachelor’s degree.

Experience:

Minimum of 5 years of clinical research experience coordinating multiple and variety of studies, e.g.,investigator initiated; industry sponsored; multi-site trials.Coordinating multiple and a variety of studies, e.g., investigator initiated, industry sponsored, multi-site trials.

Licenses and Certifications:

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

Technical Skills or Knowledge:

Train junior CRCs.Participate in protocol review and clinical trials evaluations.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.

Preferred Competencies

​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.

Working Conditions

Bend, crouch, or stoop.Lift loads up to 49 lbs.Hybrid position with majority of work being done in-person/ on-site.

Application Documents

Resume/CV (required)


When applying, the document(s) MUST be 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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