The University Of Chicago
Senior Clinical Research Coordinator
The University Of Chicago, Chicago, Illinois, United States, 60290
Senior Clinical Research Coordinator
Senior Clinical Research CoordinatorApply
Locations: Chicago, IL
Time Type: Full time
Posted on: Posted 5 Days Ago
Job Requisition ID: JR27600
Department
BSD MED - Pulmonary - Clinical Research Staff
About the Department
The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of excellence in each of these important activities.
Job Summary
The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Section Administrator and/or Clinical Research Manager within the Section of Pulmonary/Critical Care Medicine 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 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.
Responsibilities
Leads within the department/unit through improving clinical research practice and serves as a resource to others.
Works with the PIs, department, sponsors, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
Assists with or plans and implements the clinical study's goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data.
Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
Serves as a resource person or acts as a consultant within area of clinical expertise.
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 (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 (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
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.
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.
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:
Master's degree.
Experience:
Clinical research experience coordinating multiple and variety of 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)
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
37.5
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.
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.
About UsThe University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.
We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.
#J-18808-Ljbffr
Senior Clinical Research CoordinatorApply
Locations: Chicago, IL
Time Type: Full time
Posted on: Posted 5 Days Ago
Job Requisition ID: JR27600
Department
BSD MED - Pulmonary - Clinical Research Staff
About the Department
The Section of Pulmonary and Critical Care Medicine has been a model of exemplary patient care, research, and post-doctoral training for more than 20 years. The 30 faculty, clinical associates and research associates along with a staff of more than 72, have devoted themselves to the pursuit of excellence in each of these important activities.
Job Summary
The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Section Administrator and/or Clinical Research Manager within the Section of Pulmonary/Critical Care Medicine 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 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.
Responsibilities
Leads within the department/unit through improving clinical research practice and serves as a resource to others.
Works with the PIs, department, sponsors, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
Assists with or plans and implements the clinical study's goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data.
Acts as a liaison with medical staff, University departments, ancillary departments and/or satellite facilities.
Serves as a resource person or acts as a consultant within area of clinical expertise.
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 (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 (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
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.
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.
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:
Master's degree.
Experience:
Clinical research experience coordinating multiple and variety of 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)
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
37.5
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.
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.
About UsThe University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.
We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.
#J-18808-Ljbffr