Department: MED-NU-CATS Institute Salary/Grade: EXS/8
Job Summary: Manages all activities associated with highly complex clinical research studies. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. Creates and nurtures collaborations and partnerships with outside affiliate institutions, clinical research organizations, and pharmaceutical partners. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
The Recruitment Services Clinical Operations Manager is responsible for strategic and day-to-day management of the NUCATS Institute’s Center for Clinical Research recruitment program. This position directs and provides development and execution of research study recruitment plans/strategies, institutional initiatives to support recruitment, and client specifications. In addition, this role collaborates with informatics experts and others in development of new electronic medical record-based registry and recruitment procedures, and leads and monitors progress of cross-functional team in delivery of recruitment plans and attainment of key drivers affecting established objectives of overall recruitment program (e.g., recruitment costs, number of studies meeting enrollment targets, client satisfaction). In addition, this position oversees day-to-day operations, including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans/participant recruitment strategies; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; and resolving or escalating issues in a timely manner.
Furthermore, this position may co-author scientific papers for presentation & publication, and ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
This position will provide significant input into the development of SOPs and training programs for Northwestern investigators and study team members, with a focus on maximizing success of research study recruitment strategies.
Lastly, this position works extensively to create and nurture collaborations and partnerships with outside affiliate institutions, nationally recognized clinical research organizations, and pharmaceutical partners.
Develop, coordinate, and oversee initiatives, technical assistance, and resource materials to assist studies in recruitment and retention activities.
Develop, implement, and track progress of CCR recruitment program strategy across the institution’s stakeholders in collaboration with internal and external partners and their constituents.
Assists with determining goals, objectives, outcome measurements and metrics, recharge feasibility, and collaboration opportunities as it relates to clinical research recruitment with other internal and external organizations.
Directs actions to ensure high quality clinical research standards are maintained across all partner programs.
Recruit, hire, train, and supervise recruitment and other relevant research staff across partner programs.
Assists with determining goals, objectives, outcome measurements and metrics, financial feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations. Implements policies, procedures, and training for partners.
Directs actions to ensure high quality clinical research standards are maintained across all partner programs.
Provides complex technical leadership in determining research priorities & the plan, design & execution of research recruitment projects ensuring that programs of investigation meet specified recruitment/enrollment objectives.
Oversees and guides the development and execution of recruitment strategies along with recruitment, enrollment and advertisement submission, documentation, and reporting processes recommending alternatives to ensure compliance and approval.
Responsible for the editorial direction, design, production, and distribution of study- and program-specific research study recruitment materials and resources.
Trains and advises research staff on clinical trial recruitment strategies and local, state, & federal regulatory guidelines, requirements, & laws associated with research study recruitment.
Interprets and effectively communicates existing and/or new regulatory requirements, developments and Institutional Regulatory Board Policies as they relate to recruitment in human subjects research. Maintains current knowledge of federal and institutional guidelines and requirements governing research study recruitment. Recommends and implements recruitment process improvements.
Communicates with IRB and administrative units, project sponsors and project staff to develop and implement recruitment strategies. Monitors study recruitment and retention activities and coordinates recruitment project start-up with other CCR programs, study sponsors, investigators, and the IRB.
Tracks study recruitment progress to ensure uninterrupted project approval. Maintains recruitment project database and manages submission of recruitment materials, documentation, and reporting processes with media vendors, study sponsors, research teams, and the IRB.
Initiates and maintains partnerships with internal/external staff regarding community outreach engagement initiatives related to clinical research including the development and/or review of community based education programs, print and web materials, and training competencies regarding clinical research, recruitment, participation, and retention.
Oversees recruitment and management of recruitment staff.
Completes and obtains appropriate approvals from various groups for all necessary recruitment plan development and execution.
Develops, implements, and measures success of new processes, policies, and protocols to support and maximize research study recruitment.
Ensures timely completion of all recruitment materials and deliverables associated with the development and implementation of research study recruitment strategies.
Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
Ensures appropriate allocation & compliance.
Responsible for management of the recruitment recharge center including negotiating study support needs, generating and managing service agreements, recruitment coordinator time tracking, study invoicing and reconciliation, and reports.
Develop short- and long-term plans and budgets for the recruitment program and its activities, monitor progress, assure adherence and evaluate performance to ensure projects supporting program goals and objectives are within scope, on time, and on budget.
Recruit, train, appraise, supervise, support, develop, promote and guide qualified recruitment staff. Design, support, and oversee cross-functional teams within CCR Recruitment Program.
Provide support for staff regarding federal, state and institutional requirements related to research study recruitment. Monitor skill level of staff in relation to non-procedural issues and provide instruction where necessary. Serve as a resource to the clinical trials staff, evaluating opportunities to improve productivity and operational efficiency.
Provides training on any new office policies and procedures.
Supervises interactions with study sponsors, media vendors, Clinical Research Organizations, research teams, and community stakeholder organizations.
Ensures the functioning of the office is efficient by providing supervision of day to day activities of multiple teams. This position will manage administrative issues related to work load for the staff, including activities such as tracking current and expected workloads and assigning new protocols to coordinators. Assists with design and edits of recruitment documents to ensure compliance with sponsor and institutional regulations and requirements.
Contribute to the development of a high performing Recruitment and CCR team as measured through achievement of CCR and NUCATS goals and feedback from peers and leadership.
Minimum Qualifications: (Education, experience, and any other certifications or clearances)
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 7 years' research study or other relevant experience required; OR Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience.
Supervisory or project management experience required.
Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Communication-Oral and Written - Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar.
Team Player - Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement.
Organization - Organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources
Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines.
Communications and/or marketing experience.
Computer expertise include being literate in Microsoft Office, database use and management, internet research, web content software/layout, data collection tools, and Adobe Creative Suite.
Preferred Qualifications:(Education and experience)
Master’s or other graduate level degree or the equivalent of education, training and experience from which comparable skills can be acquired.
Experience in developing communications/marketing strategies and overseeing the design and production of print and digital materials and publications.
Preferred Competencies: (Skills, knowledge, and abilities)
Education/experience with social media, web design and graphic arts.
Project Management or Program Development experience
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 35706
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.