Clinical Operations Manager FSM/CC

Target hiring range for this position is between $87,900 - $126,015. 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.

About the Role

Manages all activities associated with highly complex clinical research studies including Investigator Initiated Trials, National Cooperative Group Trials, Industry Trials, with multiple affiliate institutions, and global Sponsored Trials which generate approximately $70M-$80M in revenue for the institution.

Responsibilities

• Plans and executes clinical trial programs for assigned disease teams with focus on FDA registered trials
• Serves as subject matter expert with internal and external contacts at various management levels concerning clinical operations of trial portfolios for assigned disease teams
• Regularly interacts with executive management on workflow management that impacts organizational goals
• Provides technical expertise to staff for development of clinical trial documents and records (protocols, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, etc.) and trial conduct
• Oversees reviews of studies for feasibility and budget related to multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; and/or multi-million-dollar budgets
• Ensures completion of contract requirements and client specifications
• May co-author scientific papers for presentation and publication and coordinates writing, submission and 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 and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH)
• Under direction of the Administrative Director Clinical Trials, supervises the 3 clinical research teams including 2 clinical research nurses, approximately 10 clinical research coordinators, and approximately 10 data assistants
• Organizes, plans, and controls workflow of the clinical staff within the assigned teams
• Responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines
• Provides significant input into the development of SOPs and training programs for clinical staff
• 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
• Performs other duties as assigned

Requirements

• Bachelor’s degree in a health sciences-related course of study or equivalent
• Three years of supervisory experience or equivalent
• Five years’ experience working in a clinical trials/research study capacity or equivalent
• 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
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
• Clinical Research Coordinator Certification. If certification has not been obtained upon hire, attainment will be required within 9 months of hire

Benefits

• Health, dental, vision, disability, and life insurance
• Paid vacation and holidays
• Paid medical/sick and parental leave
• Tuition benefits for the employee and dependents
• Pre-tax and flex spending accounts for commuting and dependent care
• Generous retirement savings options
• Wellness programs
• Work-life and wellness programs including flexible work arrangements, childcare and senior/adult care support
• Professional growth and development opportunities