Department
BSD ALL - Research
About the Department
Job Summary
Responsibilities
Assist the Director of Protocol Operations in assessing overall workload and assigning committee and study responsibilities.
Train, direct and monitor the work of protocol coordinators to ensure accuracy and adherence to external and internal timelines.
Conduct meetings with assigned protocol coordinators, and, on occasion, senior protocol coordinators, to implement and ensure compliance with standard operating procedures.
Manage vacation, sick leave, and other absences, as well as annual employee evaluation process for assigned protocol coordinators with oversight from Director of Protocol Operations. Assist the Director of Protocol Operations in the selection of candidates and in hiring process for new protocol coordinators.
Assist the Director of Protocol Operations in the development and implementation of relevant policies, procedures, and guidelines for protocol operations.
Assist the Director of Protocol Operations in the execution of the Central Protocol Operation Program’s mission statement, as well as the Alliance’s overall strategic plan.
Manage committee activities and committee study teams in the development and implementation of Alliance protocols.
Draft protocol and consent documents, model protocol templates, ensuring compliance with federal guidelines, the Alliance model protocol, and current Alliance policy and procedures.
Format, proofread, and edit protocols for designated committee assignments.
Distribute protocol drafts for review, integrate technical and scientific information from multiple sources and incorporate necessary revisions under the supervision of Alliance Executive Officers and other senior leadership, as necessary.
Work with Alliance Executive Officers and other senior leadership, as necessary, to identify and resolve impediments to protocol development process.
Act as liaison to funding agencies (NCI CTEP and DCP staff), the Cancer Trials Support Unit (CTSU), and the NCI Central Institutional Review Board (CIRB), regarding studies in development or undergoing revision, and monitor progress of review performed by these organizations. Identify and seek resolution of issues raised during the course of review by these agencies.
In collaboration with study team, prepare response to reviews, make all necessary revisions to the protocol document, and submit all necessary supporting documentation.
In conjunction with Executive Officer and Director of Pharmaceutical and Regulatory Affairs, ensure that protocols meet pharmaceutical collaborator requirements.
Prepare amendments for active protocols as necessary.
Obtain necessary approvals, including submission, if necessary to the Alliance Data and Safety Monitoring Board, other Alliance committees charged with oversight and approval, the CIRB, and NCI CTEP/DCP.
Prepare and distribute amendments to the group membership.
Identify emergent issues arising during development and implementation of studies and seek resolution of such issues. Implement emergency procedures, as required, in conjunction with Executive Officers, Director of Protocol Operations, Director of Pharmaceutical and Regulatory Affairs, etc.
Field telephone and email inquiries regarding study conduct from clinical research and health-related professionals, including data managers, nurses, and physicians.
Attend group meetings, core committee meetings and other meetings as assigned.
Report at meetings, as necessary, the status of protocols under development or in progress.
Provide information and assistance regarding protocol development procedures.
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
Education:
Master’s degree in biology, public health or in another scientific or health-related field is strongly preferred.
Bachelor’s degree will be considered if accompanied by a minimum of 4 years of experience in oncology clinical trials in an academic or community medical center or pharmaceutical industry.
Experience:
Experience in research or scientific writing.
Experience with clinical trials research.
Preferred Competencies
Must have the ability to communicate well with group members, as well as representatives from industry and federal agencies.
Must have excellent verbal and written communication skills demonstrated in a research or scientific setting.
Must have the ability to handle multiple tasks and assignments simultaneously.
Must have excellent organizational and leadership skills.
Working Conditions
Must be willing to travel approximately 5% of the year.
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.
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Skills Required
- College or university degree in a related field
- 2-5 years of relevant work experience in clinical research or related discipline
- Resume submission via application (required)
- Master's degree in biology, public health, or related scientific/health field
- Bachelor's degree plus minimum 4 years oncology clinical trials experience
- Experience in research or scientific writing
- Experience with clinical trials research
- Excellent verbal and written communication skills in a research or scientific setting
- Ability to handle multiple tasks, strong organizational and leadership skills
What We Do
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to rigorous inquiry and intellectual freedom draws pathbreaking scholars to our global campuses, where field-defining ideas are born that challenge and change the world. The University of Chicago has its main campus on Chicago's South Side and seven international campuses and centers throughout the world. Students can choose from 53 majors and 47 minors in the undergraduate College, with four divisions and seven professional schools for graduate study.
