Department: MED-Medical Social Sciences Salary/Grade: EXS/8
Manages all activities, including reviewing feasibility and budgets, associated with social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, clinical trials and longitudinal assessments/ interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. 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. May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. 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 entails operational management across the multiple funded studies by Dr. Laurie Wakschlag within the Department of Medical Social Sciences. This is a unique opportunity to be involved in innovative developmental science research that include large, transdisciplinary teams across institutions to move the dial on our current understanding of infant health and development.
The research of this program aims to examine early markers of risk to social-emotional well-being starting in the first years of life, including a focus on early identification, intervention, and prevention. The Clinical Operations Manager will be involved in a program with several large-scale transdisciplinary projects. The projects have multiple collaborators such as Ann and Robert H. Lurie Children’s Hospital, Washington University School of Medicine and the Shirley Ryan AbilityLab. These longitudinal studies are funded by the National Institute of Health as well as philanthropically. Across all projects multiple state-of-the-art, developmentally sensitive methods are used with interdisciplinary investigative teams that include expertise in clinical, developmental and quantitative psychology, developmental epidemiology, computer science, engineering, communication science, prevention science and developmental cognitive neuroscience.
This Clinical Operations Manager position requires a dynamic and highly motivated individual with a strong attention to detail who can also consider the big picture. Looking for a team player who prefers open and direct communication and is willing to take initiative and learn a variety of responsibilities. Individual needs to be comfortable with managing a multi-disciplinary team and can communicate with people from a variety of backgrounds, including investigators, research staff, and diverse child and parent participants. Flexibility, ability to think on your feet, and a capacity to lead energetically and by example are key. Flexibility in hours is required including evening and weekend hours, and may include off-site activities. Ability to provide and receive constructive feedback are essential. The manager will work closely with the investigative team in ensuring that studies achieve their objectives.
This is a one-year term position with opportunity for renewal will be based on performance and available funding.
Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
Directly involved with study start-up, implementation, conduct, and close-outs.
Manages day to day activities of clinical research teams and oversees interaction with critical clinical partners such as pharmacy, nursing, pathology core, NMDTI, etc…
Ensures that the conduct of study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
Trouble-shoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
Leads clinical teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits.
Works directly with the CRO’s Quality Control Manager on the development of standard operating procedures for clinical staff and also monitors compliance with procedures.
Serves as contact between clinical staff and multiple NM and NU departments on issues related to clinical research coordination.
Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
Oversees recruitment and management of clinical research staff.
Completes applications and obtains appropriate approvals from various groups (CSRC committee, CRU, IBS, Pharmacy, etc.) for all necessary study-start-up functions.
Plans, develops & implements new processes, policies, and protocols to support research studies & maximize/extend study capabilities.
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
Ensures appropriate allocation & compliance.
Invoices study sponsors for study tests/procedures.
Coordinates & participates in budgetary negotiations with industry sponsors.
Trains, directs, assigns duties to supervise clinical research coordinators and nursing staff. Assists in training of regulatory team and data assistants.
Acts as a mentor in regard to education of junior coordinators.
Monitor federal regulatory agency requirements related to clinical research training. Provide training to staff regarding federal, state and institutional requirements. 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 and CRO monitors. Directs weekly prep meetings for sponsor/monitor visits.
Ensures the clinical functioning of the office is efficient by providing supervision of day to day activities of multiple teams of cllinical research coordinators (CRCs), Clinical Research Nurses (CRNs), and data assistants. Responsible for interviewing, hiring and evaluating the aforementioned staff . 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 internal audits of research charts to ensure compliance with protocol requirements.
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.
Directs actions to ensure high quality clinical research standards are maintained across all partner programs.
Recruit, hire, train, and supervise clinical research staff across partner programs.
Performs other duties as assigned.
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 NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Clinical Research Coordinator Certification. If not currently obtained, will be required within 9 months of hire.
Minimum Competencies: (Skills, knowledge, and abilities.)
Excellent written and oral communication skills
Strong organization and interpersonal skills.
Computer expertise include being literate in Microsoft Office, Internet and database use.
Bachelor’s degree in psychology, public health, or related field or organizational management within a research context.
3-5 years research study experience.
Project Management Certification.
Experience managing human subjects research.
Experience managing teams of people with several direct reports.
Experience with data and database management.
Experience working with families and children in community-based programs or research.
Outstanding written and spoken communication skills in English. The role requires someone with a strong research and clinical background to help manage several projects
Preferred Competencies: (Skills, knowledge, and abilities)
Previous experience at a research institution or University.
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: 38962
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.