The University Of Chicago
Senior Clinical Research Coordinator
The University Of Chicago, Chicago, Illinois, United States, 60290
Senior Clinical Research Coordinator
Apply remote type Onsite locations Chicago, IL time type Full time posted on Posted 5 Days Ago job requisition id JR28586
Department
BSD MED - Emergency Medicine
About the Department
The Emergency Trials Unit (ETU), a team within the section of Emergency Medicine, enrolls patients from the Emergency Department in industry and grant funded research studies and trials. In addition, we partner with other departments, such as Neurology and Trauma, in their clinical research studies.
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). The Sr CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in ensuring compliance with federal and institutional regulations.
Responsibilities
Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
Serve as a resource person or act as a consultant within area of clinical expertise.
Maintain working knowledge of current protocols, and internal SOPs.
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Provide Investigators with guidance regarding protocol requirements.
Maintain regulatory documentation.
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
Accountable for all tasks in complex clinical studies.
Performs various professional, organizational, and operational tasks under limited supervision.
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.
Preferred Qualifications
Education:
Advanced degree.
Experience:
Experience coordinating multiple and a 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).
Application Documents
Resume/CV (required)
Cover Letter (required)
Job Family
Research
Scheduled Weekly Hours
40
Drug Test Required
Yes
Health Screen Required
Yes
Pay Rate Type
Salary
FLSA Status
Exempt
Pay Range
$65,000.00 - $90,000.00
Benefits Eligible
Yes
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
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.
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Department
BSD MED - Emergency Medicine
About the Department
The Emergency Trials Unit (ETU), a team within the section of Emergency Medicine, enrolls patients from the Emergency Department in industry and grant funded research studies and trials. In addition, we partner with other departments, such as Neurology and Trauma, in their clinical research studies.
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). The Sr CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in ensuring compliance with federal and institutional regulations.
Responsibilities
Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
Serve as a resource person or act as a consultant within area of clinical expertise.
Maintain working knowledge of current protocols, and internal SOPs.
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Provide Investigators with guidance regarding protocol requirements.
Maintain regulatory documentation.
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
Accountable for all tasks in complex clinical studies.
Performs various professional, organizational, and operational tasks under limited supervision.
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.
Preferred Qualifications
Education:
Advanced degree.
Experience:
Experience coordinating multiple and a 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).
Application Documents
Resume/CV (required)
Cover Letter (required)
Job Family
Research
Scheduled Weekly Hours
40
Drug Test Required
Yes
Health Screen Required
Yes
Pay Rate Type
Salary
FLSA Status
Exempt
Pay Range
$65,000.00 - $90,000.00
Benefits Eligible
Yes
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
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.
#J-18808-Ljbffr