Department: MED-Cancer Center
Salary/Grade: EXS/8

Job Summary:

Manages all 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 which generate approximately 70-80 million dollars in revenue for the institution.

Responsible for: reviews of studies for feasibility and budgets,  multiple investigators, teams, sites, sub-contracts, participants, 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).

Under direction of the Administrative Director Clinical Trials, this position supervises the 3 clinical research team including 2 clinical research nurses, approximately 10 clinical research coordinators, and approximately 10 data assistants on a day-to-day basis. This manager will organize, plan, and control work flow of the clinical 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.

This position works on policies and procedures with various departments within the institutions (including but not limited to CRU, NUCATS, Ophthalmology, Transplant, Pathology, Radiology, Pharmacy, Women’s Cancer Center, In-patient nursing, etc..) to ensure proper conduct of clinical trials.

Additionally, this position works extensively with Cancer Center leadership to create and nurture collaborations and partnerships with outside affiliate institutions, nationally recognized clinical research organizations, and pharmaceutical partners.

Specific Responsibilities:

Technical

• 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 nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
• 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.
• 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.
• Serves as contact between clinical staff and multiple NM and NU departments on issues related to clinical research coordination.

Administrative

• 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.

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. 
• Invoices study sponsors for study tests/procedures. 
• Coordinates & participates in budgetary negotiations with industry sponsors.
• Works directly with Clinical Research Unit (CRG) in development of applications, nursing orders and patient flow sheets for research studies involving the CRO.  Serves as main CRG contact throughout study development and until study completion.   

Supervision/Training Activities

• Trains, directs, and 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 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.

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.

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.