Clinical Trials Manager

About the role

The 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.

Responsibilities

• Aid in assessing workload and assigning responsibilities to protocol coordinators.
• Train, direct, and monitor protocol coordinators to ensure accuracy and adherence to timelines.
• Conduct meetings with assigned coordinators and senior coordinators to implement and ensure compliance with SOPs.
• Manage vacation, sick leave, and other absences, as well as annual evaluations for coordinators.
• Select candidates and assist in the hiring process for new coordinators.
• Aid in the development and implementation of relevant policies, procedures, and guidelines for protocol operations.
• Manage committee activities and committee study teams in the development and implementation of Alliance protocols.
• Draft, format, proofread, and edit protocol documents, ensuring compliance with federal guidelines, the Alliance model protocol, and current policies.
• Work with funding agencies, CTSU, and CIRB to address study reviews and progress.
• Prepare amendments for active protocols and obtain necessary approvals, including submission to the Alliance Data and Safety Monitoring Board.
• Coordinate events, research logistics, and assist with presentations and post-event write-ups.
• Provide information and assistance regarding protocol development procedures.
• Field inquiries and attend meetings as assigned.

Requirements

• Minimum of 2-5 years of work experience in a related job discipline.
• Knowledge and skills developed through work experience in research or scientific writing.
• Experience with clinical trials research.

Qualifications

• Master’s degree in biology, public health, or another scientific or health-related field is preferred.
• Bachelor’s degree in a related field, combined with a minimum of 4 years of experience in oncology clinical trials in an academic or community medical center or pharmaceutical industry, may be considered.

Skills

• Excellent verbal and written communication skills.
• Ability to handle multiple tasks and assignments simultaneously.
• Excellent organizational and leadership skills.

Benefits

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.