Department: MED-Cancer Center
Salary/Grade: EXS/9

Job Summary:

Clinical Focus:

This position provides clinical operational management oversight for multiple operations managers of the Cancer Center Clinical Trials Office (CTO). Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Responsible for management, administration, organization and conduct of the clinical trials operations. Oversees day-to-day operations including assigning and supervising study staff to disease teams, identifying & securing needed resources, identifying the need for process improvement and developing and implementing plans. Provides leadership, training, coaching and mentoring of clinical operation supervisors and staff. Works collaboratively with operational leaders of the CC Finance, IT and other Medical School and Hospital units and departments engaged in clinical research.

Regulatory Focus:

Defines and implements regulatory strategies and priorities in conjunction with Director of Research Integrity and Compliance. Ensures application of established policies and best practice regulatory standards across network regions for all filings, maintenance of existing trial registrations and agency interactions.

May serve as primary regulatory contact with for FDA inspections. Assists Regulatory staff by outlining regulatory strategy and providing data needed to support filings, responses to Health Authorities inquiries, and trial registration maintenance. Oversees the regulatory workforce activities associated with highly complex biomedical &/or social-behavioral research studies including Investigator Initiated Trials, National Cooperative Group Trials with multiple affiliate institutions, and global Sponsored Trials.

Organizes, plans, and controls work flow of the regulatory staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff

QA Focus:

Responsible for managing the Data Quality Assurance department to provide strategy for the oversight and quality services for oncology network trial management, CTMS electronic systems, data integrity processes, and related continuous process improvement initiatives. Provides strategic leadership in driving a consistent compliance and validation approach to policies, procedures, and standards. Performs Electronic Records / Electronic Signatures regulation and related regulation surveillance to provide guidance and instruction to the Cancer Center to ensure compliance with regulatory requirements.

Anticipates and develops QA activities and processes related to electronic systems oversight based on risk. Develops staff to serve as QA representatives on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items.

Organizes, plans, and controls work flow of the QA staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff.

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).

Works extensively to create and nurture collaborations and partnerships with outside affiliate institutions, nationally recognized clinical research organizations, and pharmaceutical partners.

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.

Specific Responsibilities:

Technical

• Provide leadership support for clinical trials
• Manage and coordinate clinical study design and implementation at a program and functional level according to Good Clinical Practice (GCP) and Standard Operating Procedures
• Leads clinical teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits.
• Responsible for operational input and oversight in designing, planning, initiating and completing clinical trials across assigned disease teams
• Expected to take lead in review of clinical study documents including protocols, investigator's brochures, and clinical study reports.
• Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
• Reviews scientific literature & evaluates & recommends applicable techniques & procedures.
• 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.
• Lead clinical study and cross functional team to make key decisions related to strategy and issue resolution

Administrative

• Acts as main liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
• Oversees recruitment and management of clinical research staff mentoring and training.
• Supports and contributes to inspection readiness.
• Develop increase knowledge of clinical research and clinical operations management activities across teams and departments.
• 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.
• Maintains postings to clinical trial websites and ensures amendment information up to date

Data

• 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.

Finance

• Ensures appropriate allocation & compliance.
• Manage study budget, timelines, insourcing and outsourcing partners to required
• Coordinates & participates in budgetary negotiations with industry sponsors. 13.

Supervision/Training Activities

• 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 clinical 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.

Program Development

• 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. Will work closely with Cancer Center leadership to implement policies, procedures, and training for partners such as the VA, Lake Forest, Cadence, and any other sites NM expands to.
• 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.

Miscellaneous

• Performs other duties as assigned.

Minimum Qualifications:

• 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 5 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 3 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.

Preferred Qualifications:

• Nursing degree, Master's or other graduate level degree or the equivalent of education, training and experience from which comparable skills can be acquired.
• Past experience in hematology/oncology clinical trials preferred.
• Past experience working with clinical trials budget

Target hiring range for this position will be between $76,196 - $107,151 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.

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. Click for information on EEO is the Law.

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