University of Chicago
Education
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Department
BSD ALL - Research
About the Department
Job Summary
Responsibilities
Provides materials for protocol development to study chairs and assistance in implementing protocol development policies and procedures.
Formats, proofreads, and edits protocols. Distributes protocol drafts for review, integrates technical and scientific information from multiple sources, and incorporates necessary revisions.
Ensures protocol compliance with the Alliance model protocol and current policies and procedures, and federal regulatory requirements and guidelines.
Sets schedule for each protocol under development and ensures that all members of the study team (study chair, committee chair, statistician and data coordinator) adhere to timeline as closely as possible. Works closely with Executive Officers and study teams to identify and resolve impediments to the development process.
Acts as liaison to funding agencies (NCI CTEP and/or DCP) staff, the Cancer Trials Support Unit (CTSU), and the NCI Central Institutional Review Board (CIRB) regarding studies in development or undergoing revision, and monitors progress of review performed by these organizations.
Identifies and seeks resolution of issues raised during the course of review.
In collaboration with study team, prepares response to review, makes all necessary revisions to the protocol document, and submits all necessary materials.
In conjunction with the Executive Officer, ensures that protocols meet pharmaceutical sponsor requirements. Drafts or assists in drafting of model patient consent form, ensuring compliance with federal guidelines and templates for informed consent documents.
Prepares amendments for active protocols as required. Obtains necessary approvals, including submission to the Alliance Data and Safety Monitoring Board, the CIRB, and CTEP. Prepares and distributes amendments to the group membership via the Alliance website.
Identifies emergent issues arising during development and implementation of studies and seeks resolution of such issues. Implements emergency procedures as required.
Fields telephone queries from clinical research associates, nurses and physicians at Alliance institutions regarding conduct of studies. Responsible for addressing administrative issues and referring scientific/medical inquiries to the appropriate individuals as needed.
Coordinates events, researches logistics, assists with planning and preparing presentations, event outreach, and post-event write ups.
Assists with other administrative projects as needed and acquire higher level guidance and skills.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Experience:
Some clinical research experience desired.
Preferred Competencies
Knowledge of program subject matter (health care, medicine, clinical research).
Strong analytical and problem- solving skills.
Attention to detail.
Strong organizational skills.
Strong oral and written skills.
Decision-making skills.
Strong interpersonal and customer service skills.
Ability to work independently and as part of a team.
Ability to work on multiple projects simultaneously, set priorities and meet deadlines.
Application Documents
Resume (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
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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.
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.
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.
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