Clinical Trials Manager

Department

BSD ALL - Research

About the Department

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.

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 proce