Research - Laboratory/Non-Laboratory, Staff/Administrative
Department: MED-Dermatology Salary/Grade: EXS/8
Manages all activities associated with complex clinical research studies and provides leadership and advanced problem solving in support of the department’s research program and mission. 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, research sponsors, and various departments within the institution. 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).
Responsible for review of studies for logistical and financial feasibility and ensures completion of contract requirements & client specifications. Will develop policies, SOPs and training programs for research staff throughout the department of Dermatology to ensure proper conduct of human subjects research.
This position supports the mission, vision and strategic plan of the Department of Dermatology. The manager will collaborate with the Director of the Dermatology Clinical Trials Unit to ensure exceptional clinical research support and a high level of professionalism and quality customer service. The Manager focuses others on a clearly defined, clearly communicated vision and engages individuals and groups to achieve that vision. The Manager identifies and develops organizational talent and embraces continuous learning of self and others.
Please Note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.
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 clinical research within the department.
Directs actions to ensure high quality clinical research standards are maintained across all department divisions.
Recruit, hire, train, and supervise junior clinical research staff.
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.
Oversees completion of study activities per protocol. Guides clinical research coordinators in collaborating with local clinical staff and Principal Investigator (PI).
Manages day-to-day activities of clinical research team and oversees interaction with critical clinical partners such as physicians, pharmacists, and research technicians.
Ensures that the conduct of study protocols is 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 the study or study sponsors.
Leads research staff in preparing for internal, NU IRB, Sponsor, and/or FDA audits.
Develops and maintains standard operating procedures for clinical research staff and also monitors compliance with procedures.
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 for all necessary study start-up functions.
Plans, develops & implements new processes, policies, and protocols to support research studies & maximize/extend study capabilities.
Provides supervision of day-to-day research activites and manges administrative issues related to work load for the staff, including activities such as tracking current and expected workloads and assigning new protocols to coordinators and assistants. Assists with internal audits of research charts and data to ensure compliance with protocol requirements.
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Manages project data including creation and management of databases, monitoring for data accuracy, and evaluation and analysis of data ensuring that results meet project information and deliverable objectives.
Analyzes, evaluates & interprets data to determine relevance to research
Monitors data use and storage to ensure compliance with current local, state, & federal regulatory guidelines, requirements, laws
Coordinates & participates in budgetary negotiations with industry sponsors.
Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
Assists with the management of research study budgets, which may include deciding on & approving expenditures of funds based on budget
Trains, directs, and assigns duties to clinical research and regulatory staff.
Acts as a mentor in regard to education of junior coordinators.
Monitor institutional and 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 research staff, evaluating opportunities to improve productivity and operational efficiency.
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
Supervisory or project management experience required.
Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Certification in clinical research (i.e. CCRC or CCRP) through ACRP or SOCRA
Clearance by NMHC Access Program
Minimum Competencies: (Skills, knowledge, and abilities.)
Excellent written and oral communication skills.
Strong organization and interpersonal skills.
Attention to detail / ability to work flexibly across multiple projects at a time.
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Master’s degree in public health, biostatistics or statistics or other social or health sciences; or equivalent level of education or experience.
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledge of medical/institutional research procedures
Proficiency in REDCap
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: 40810
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.