Clinical Trials Manager

The University of Chicago; Chicago (IL); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Retirement plan

Job summary

The University of Chicago is seeking a Clinical Trials Manager to oversee planning and execution of multiple oncology research studies within the Alliance for Clinical Trials in Oncology. The role supervises protocol coordinators, ensures timelines, and maintains compliance across committees and external regulators.

Successful candidates will coordinate with senior leadership, develop and revise protocols, and manage review processes with CIRB, NCI CTEP/DCP, and CTSU to advance trial activities.

Qualifications

• Education: college/university degree in related field.
• Work Experience: 2-5 years in a related job discipline.
• Preferred: Master's degree in biology/public health or oncology trials experience.
• Excellent communication and leadership skills as demonstrated in a research setting.

Responsibilities

• Assist Director of Protocol Operations in workload assessment and task assignment.
• Train and monitor protocol coordinators to ensure timelines.
• Conduct meetings to ensure SOP compliance and oversee staff performance.
• Coordinate with funding and regulatory bodies (NCI CTEP/DCP, CIRB, CTSU).
• Prepare amendments and protocol documentation for reviews and approvals.
• Attend meetings and report progress on protocols under development.

Skills

Leadership

Communication

Organization

Problem solving

Team coordination

Education

Bachelor's degree

Master's degree preferred

Tools

MS Office

Regulatory systems

Job description

DepartmentBSD ALL - ResearchAbout the DepartmentThe Alliance for Clinical Trials in Oncology (Alliance) is a National Cancer Institute (NCI) sponsored research organization with over 100 member networks (over 1200 research sites). The Alliance for Clinical Trials in Oncology at the University of Chicago serves as the office for scientific protocol, administrative, regulatory and pharmaceutical affairs operations of the Alliance.

Job Summary

The Clinical Trials Manager will manage and coordinate a variety of complex and independent activities involved with planning and conducting multiple research studies for the Alliance. The Central Protocol Operations Program is a program within the Alliance for Clinical Trials in Oncology, a national cooperative group sponsored by the National Cancer Institute. The Clinical Trials Manager serves as an in-house manager who oversees protocol coordinators who are responsible for developing research protocols in a timely and efficient manner.

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: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
• Certifications: ---

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: 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.

Pay Range

$60,000.00 - $85,000.00

Benefits EligibleYes

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.