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Clinical Trials Monitor

Job description



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/

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Job No:
Posted: 12/1/2018
Application Due: 1/30/2019
Work Type:
Salary: