Alliance for Clinical Trials in Oncology

Project Manager

• This role provides administrative and project coordination support for the Foundation’s Cancer Control Program (CCP) and Cancer Care Delivery Research (CCDR) activities
• It supports committee operations, meeting and event planning, protocol and membership tracking, and communication workflows
• Working closely with program leadership and internal and external partners, the position helps ensure smooth execution of CCP/CCDR projects and maintains key documentation, databases, and operational processes
• Works in close partnership with the CCDR Committee Chairs
• Manages activities of CCP/CCDR committee, such as routes new membership requests according to SOPs
• Maintains and updates membership rosters for CCP and CCDR Committee(s), including guiding potential existing and new members on CTEP IAM rostering requirements
• Track virtual/ in person attendance at all CCP/CCDR committee, Sub-committee, working group and ad-hoc meetings for inclusion in the minutes
• Maintain updated distribution lists for all meetings and communications
• Works with the CCP Program Manager on building surveys in Survey monkey for distribution to community members, download results and update the tracker
• Provide Alliance Publications policies to investigators on study completion and track abstract and manuscript status
• Liaises with NCI personnel, Alliance Statistics and Data Management Center and Alliance protocol office for CCDR and CCP studies
• Coordinates the bi-annual Alliance group meeting specific to CCP/CCDR sessions, including identification of funded travelers, contributing to session agendas, helping to draft committee presentations, and helping to facilitate committee meetings
• Point person to triage requests from external research collaborators and internal Alliance personnel for interaction with CCDR committee
• Assists with the development and execution of CCDR studies
• Engages closely with investigators, participating sites and coordinates study team/site meetings to enable the smooth conduct of Alliance clinical trials, providing project management support as needed
• Assists the CCP Program Manager in coordinating and tracking Cancer Control Program (CCP) and Cancer Care Delivery Research (CCDR) concepts and protocols from initiation to completion in order to update the study tracker and provide most recent updates to leadership
• Helps to plan agendas and facilitate meetings with investigators for ongoing CCDR projects
• Request permissions for Quality-of-Life measures used in CCDR trials working with the CCP Program Manager
• Assists in daily operations related to managing of Cancer Control Program (CCP) and Cancer Control Delivery Research (CCDR) projects
• Coordinate NCORP CCDR grant funded pilots including solicitation of applications, selection and track progress of awarded pilot projects
• Provides administrative support to Foundation or its wholly owned subsidiaries
• Works with the CCP Sr. Program Manager and Committee chair(s) to plan standing CCP committee and sub-committee meetings and working groups, generating draft agendas, minutes, scheduling meetings with stakeholders as needed
• Prepares, collects and distributes presentations, notices, agendas, meeting minutes and other documentation/communications
• Assists with document management system including but not limited to set up, entry, review and document maintenance
• Coordinates meetings and events, researches logistics, assists with planning and preparing presentations, event outreach, and post-event write ups/minutes
• Assists with the assembly of teams and the development of detailed work plans, schedules, resource plans, and status reports
• Develops and maintains various databases, process flows and/or spreadsheets. Collects and distributes reports, information and other materials, in collaboration agreements and/or regulatory requirements
• Performs other related duties as requested

Cancer Control and Care Delivery Research Project Coordinator

Human Resources

• Design and implement supervisor development programs to build leadership, communication, and people-management skills
• Lead the design and administration of the performance management framework, including SMART goal setting, competency assessments, and feedback cycles
• Manage the annual evaluation cycle, conduct benchmarking and compensation analyses, and provide recommendations for merit increases, promotions, and bonuses
• Develop and maintain the organization’s job architecture framework, career ladders, and succession planning strategies
• Provide leadership and direction through managers responsible for designing, implementing, and monitoring human resource initiatives
• Manage employees by establishing annual performance goals, allocating resources, assessing performance, and determining merit, incentive, and promotional increases
• Advise management on compliance with federal, Illinois and Massachusetts state, and Chicago and Boston local employment laws and regulations
• Develop short- and long-term HR plans, operational policies, and oversee project development, implementation of initiatives, office procedures, and policy compliance
• Serve as the lead HR partner for the Alliance Foundation, managing end-to-end hiring including job descriptions, postings, interviews, hiring, performance management, and accrual administration
• Coordinate space and office assignments, staff training programs, staff meetings, and maintain HR files and records
• Oversee performance reviews, corrective action processes up to and including termination, and provide supervision, guidance, and training
• Act as lead liaison for labor relations, job postings, classifications, employee benefits, payroll, and leave administration
• Collaborate with Finance/Budget to administer the HR budget and monitor departmental expenses

Human Resources Manager

• Acts as operations lead on one or more AFT studies
• Serves as primary point of contact between AFT and pharmaceutical industry partners associated with assigned AFT studies
• Assists with the design, planning, implementation, conduct, and management of clinical studies from initiation through completion
• Represents AFT Clinical Operations on the cross‐functional project team, and liaises with medical, statistical, regulatory, quality, and financial personnel
• Manages one or more AFT junior operations staff
• Oversees participating study vendors, including vendor agreements, statements of work, and vendor budgets
• Manages overall study budget, including approvals of all subject visit payments and vendor invoices for assigned studies
• Oversees and manages the development of study‐related documents together with the scientific team and protocol development team including, but not limited to, study protocol, informed consent forms, laboratory manuals, eTMF plans, etc.
• Assists in the design, configuration, development, and oversight of study-level systems such as EDC, eTMF, and CTMS
• Organizes, schedules, and leads study teleconferences and in-person meetings with investigative sites, physicians, vendors, and consultants as needed
• Serves as the central escalation point for all study issues originating with component groups such as data management, site management, site monitoring, laboratory management, etc., and tracks escalated issues through to resolution
• Reviews study-related materials including, but not limited to, monitoring reports, key performance metric reports, clinical trial agreements, etc. as needed
• Works with the AFT Regulatory Manager to support regulatory filings as needed
• Initiates and maintains study protocol(s) and associated amendment tracking
• Oversees site activities on assigned studies, including feasibility, activation, accrual, maintenance, and closure
• Tracks study progress and manages clinical timelines, including regulatory document collection, IRB approval, enrollment, management of clinical supplies, etc.
• Helps build and maintain relationships with site investigators and other site study staff
• Assists with the reporting of clinical data for regulatory or medical scientific purposes, including study publications
• Participates in the development and implementation of SOPs and Clinical Operations processes and systems
• Handles other duties as assigned.