Protocol Coordinator

Location
Chicago, IL
Posted
Feb 21, 2018
Institution Type
Four-Year Institution


Alliance for Clinical Trials in Oncology Chicago Office

Department
2010550 Alliance Clin Trials In Onc

About the Unit
The Alliance for Clinical Trials in Oncology is a clinical trials network sponsored by the National Cancer Institute that consists of nearly 10,000 cancer specialists at over 1000 member hospitals, medical centers and community sites across the United States and Canada. The Alliance develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as researches methods to alleviate side effects of cancer and cancer treatments.

Job Information

Job Summary:

The Protocol Coordinator manages activities of committee chairs and study teams in the development and implementation of Alliance protocols

Responsibilities:
  • Participates in study team and committee conference calls
  • 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 reviews, 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 if necessary to the Alliance Data and Safety Monitoring Board, the CIRB, and CTEP. Prepares and distributes amendments to the group membership via the Alliance web site
  • 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


Competencies:
  • Knowledge of program subject matter (health care, medicine, clinical research)
  • Analytical skills
  • Problem-solving skills
  • Decision-making skills
  • Attention to detail
  • Organizational skills
  • Oral and written communication skills
  • Interpersonal skills
  • Customer service skills
  • Ability to work independently and as part of a team
  • Ability to manage stressful situations
  • Ability to work on multiple projects simultaneously, set priorities and meet deadlines


Additional Requirements

Education, Experience and Certifications:

Education:
  • Bachelor's degree required


Experience:
  • Some clinical research experience desired


Required Documents:
  • Resume
  • Cover Letter
  • Reference Contact Information


Benefit Eligibility
Yes

Pay Frequency
Monthly

Pay Range
Depends on Qualification

Scheduled Weekly Hours
40

Union
Non-Union

Job is Exempt?
Yes

Drug Test Required?
No

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

Health Screen Required?
No

Background Check Required?

Yes

Posting Date
2018-01-12-08:00

Remove from Posting On or Before
2018-07-12-07:00

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.

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Full time
JR00222

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/

PI101289031

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