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Clinical Trials Monitor

Employer
The University of Chicago
Location
Chicago, IL

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Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details



Hyde Park Campus

Department
2012217 Medicine-Hematology/Oncology

About the Unit
The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.

Job Information

Job Summary:

The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the Section of Hematology/Oncology. Under the direction of Clinical Trials Office Leadership, s/he will assist in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. The Clinical Trials Monitor will ensure that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through a combination of remote data review and onsite monitoring visits; therefore, a willingness and ability to travel occasionally is required. The Clinical Trials Monitor is responsible for multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment.

Responsibilities:
  • Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines.
  • Adhere to the protocols' Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
  • Monitor clinical trial progress through a combination of remote data review and on site monitoring visits. Some travel will be required.
  • Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).
  • Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
  • Assist in the development and writing of clinical trial monitoring plans.
  • Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
  • Participate in regular monitoring team group meetings.


Competencies:
  • Ability to complete routine monitoring activities, monitoring reports, and effort trackers on time.
  • Ability to identify data discrepancies and/or instances of non-compliance and escalate appropriately.
  • Working understanding of DF/HCC SOPs and applicable federal and local regulations/policies.
  • Independently performs all primary duties listed above with minimal supervision.


Additional Requirements

Education and Experience:
  • Bachelor's degree required.
  • Three years of progressively responsible clinical trials experience required.
  • One year of monitoring experience required.
  • University or Academic medicine administrative experience preferred.

Required Documents:
  • Resume
  • Cover Letter

NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.

Benefit Eligibility
Yes

Pay Frequency
Monthly

Pay Range
Depends on Qualifications

Scheduled Weekly Hours
37.5

Union
Non-Union

Job is Exempt?
Yes

Drug Test Required?
Yes

Does this position require incumbent to operate a vehicle on the job?
No

Health Screen Required?
Yes

Posting Date
2018-11-30-08:00

Remove from Posting On or Before
2019-05-30-07:00

Posting Statement:

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected 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.

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.

Full time
JR03541

About Us
The 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.

To learn more about the university click here http://www.uchicago.edu/

PI106424254

Organization

An intellectual destination

One of the world's premier academic and research institutions, The University of Chicago has driven new ways of thinking since our 1890 founding. Today, The University of Chicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping The University of Chicago at the nexus of ideas that challenge and change the world.

A transformative education

Our education empowers individuals to challenge conventional thinking in pursuit of original ideas. Students in the undergraduate College broaden their perspectives on world issues in the rigorous Core curriculum. Graduate programs through our four divisions, six professional schools, and the Graham School of Continuing Liberal Arts and Professional Studies transform scholars into leaders and grant access to professors often lauded as some of the world's greatest thinkers.

Groundbreaking research

With a commitment to free and open inquiry, our scholars take an interdisciplinary approach to research that spans arts to engineering, medicine to education. Their work transforms the way we understand the world, advancing fields of study, and often creating new ones. Generating new knowledge for the benefit of present and future generations, The University of Chicago research has had an impact around the globe, leading to such breakthroughs as discovering the link between cancer and genetics, establishing revolutionary theories of economics, and developing tools to produce reliably excellent urban schooling.

A commitment to enrich society

Located in one of the world's greatest cities, The University of Chicago is enriched by and invested in the community we call home. As the second-largest private employer in Chicago, our talented faculty, physicians, and staff comprise a dedicated team committed to the mission of the University.

We partner with our South Side neighbors on innovative initiatives with local benefits and replicable outcomes for urban universities everywhere. Meanwhile, our research and ideas have broad impact, crossing borders to drive international conversations. The same is true of our diverse and creative students and alumni, who found businesses, create masterpieces, and win Nobel Prizes.

In all we do, we are driven to dig deeper, push further, and ask bigger questions—and to leverage our knowledge to enrich all human life.

Working at The University of Chicago

The University of Chicago is a vibrant community of people dedicated to the pursuit of excellence in education and research. One of the largest employers in the metropolitan area, the University employs 10,000 diverse and talented individuals who come to work here from all over the world. The University's location in the heart of an urban environment provides many cultural offerings as well as opportunities to engage with the local community.

We invite you to find out more about the many advantages of working at The University of Chicago.

Our Location: Hyde Park

The Hyde Park community is rich in tradition, culturally diverse, and brimming with art, music, and entertainment opportunities. Find out more about living and working in the Hyde Park area.

Our Benefits: An Overview

The University offers a wide array of competitive benefits, learning opportunities, and additional services to our employees. Find out more about how working at the University of Chicago could benefit you.

University of Chicago Facts:

  • 5,860 undergraduate students
  • 9,866 graduate, professional, and other students
  • 160,000 alumni world wide
  • 2,274 full time faculty
  • 7,164 staff
  • 49 majors and 40 minors in the undergraduate College
  • 5 divisions and 6 professional schools for graduate study
  • 99 Nobel Laureates
Company info
Telephone
773-834-8997
Location
6054 S Drexel Ave
Chicago
IL
60637
US

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