University of Chicago
Overview
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 1,000 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 uses the best science to develop optimal treatment and prevention strategies for cancer, as well as researching methods to alleviate side effects of cancer and cancer treatments. Department : BSD ALL - Research Job Summary
The Protocol Coordinator manages activities of committee chairs and study teams in the development and implementation of Alliance protocols. This position reports to the Director of Protocol Operations. Responsibilities
Provides materials for protocol development to study chairs and assists 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 study team members (study chair, committee chair, statistician and data coordinator) adhere to timelines. Works 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 under revision, and monitors progress of reviews by these organizations. Identifies and seeks resolution of issues raised during the course of review. In collaboration with the study team, prepares responses to reviews, makes 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 model patient consent forms, 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, CIRB, and CTEP. Prepares and distributes amendments to group members via the Alliance website. Identifies emergent issues arising during development and implementation of studies and seeks resolution. Implements emergency procedures as required. Handles telephone inquiries from clinical research associates, nurses and physicians at Alliance institutions regarding study conduct. Addresses administrative issues and routes scientific/medical inquiries appropriately. 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 seeks higher level guidance and skills. Performs other related work as needed. Qualifications
Education : Minimum qualifications include a college or university degree in a related field. Work Experience : Minimum qualifications include 2-5 years of work experience in a related job discipline. Certifications : (Not specified) Preferred Qualifications 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 communication skills. Decision-making skills. Strong interpersonal and customer service skills. Ability to work independently and as part of a team. Ability to manage multiple projects, 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 Details
Job Family: Administration & Management Role Impact: Individual Contributor Scheduled Weekly Hours: 40 Drug Test Required: No Health Screen Required: No Motor Vehicle Record Inquiry Required: No Pay Type: Salary FLSA Status: Exempt Pay Range: $60,000.00 - $85,000.00 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. 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 identity, or expression, national or ethnic origin, ancestry, age, disability status, 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 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. The University considers conviction information on a case-by-case basis.
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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 1,000 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 uses the best science to develop optimal treatment and prevention strategies for cancer, as well as researching methods to alleviate side effects of cancer and cancer treatments. Department : BSD ALL - Research Job Summary
The Protocol Coordinator manages activities of committee chairs and study teams in the development and implementation of Alliance protocols. This position reports to the Director of Protocol Operations. Responsibilities
Provides materials for protocol development to study chairs and assists 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 study team members (study chair, committee chair, statistician and data coordinator) adhere to timelines. Works 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 under revision, and monitors progress of reviews by these organizations. Identifies and seeks resolution of issues raised during the course of review. In collaboration with the study team, prepares responses to reviews, makes 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 model patient consent forms, 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, CIRB, and CTEP. Prepares and distributes amendments to group members via the Alliance website. Identifies emergent issues arising during development and implementation of studies and seeks resolution. Implements emergency procedures as required. Handles telephone inquiries from clinical research associates, nurses and physicians at Alliance institutions regarding study conduct. Addresses administrative issues and routes scientific/medical inquiries appropriately. 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 seeks higher level guidance and skills. Performs other related work as needed. Qualifications
Education : Minimum qualifications include a college or university degree in a related field. Work Experience : Minimum qualifications include 2-5 years of work experience in a related job discipline. Certifications : (Not specified) Preferred Qualifications 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 communication skills. Decision-making skills. Strong interpersonal and customer service skills. Ability to work independently and as part of a team. Ability to manage multiple projects, 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 Details
Job Family: Administration & Management Role Impact: Individual Contributor Scheduled Weekly Hours: 40 Drug Test Required: No Health Screen Required: No Motor Vehicle Record Inquiry Required: No Pay Type: Salary FLSA Status: Exempt Pay Range: $60,000.00 - $85,000.00 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. 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 identity, or expression, national or ethnic origin, ancestry, age, disability status, 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 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. The University considers conviction information on a case-by-case basis.
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