Clinical Research Manager

Clinical Research ManagerFounded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.The UCI Center for Clinical Research (CCR) is driven to improve health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic.ResponsibilitiesUnder the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Clinical Research Manager (CRM) is responsible for all clinical research operational matters in fulfilling the mission of CCR under the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. Serving as an administrative and operational leader, the Manager oversees multiple Supervisors and their respective specialty units, and is accountable for unit-level operational effectiveness across multiple specialties and clinical locations. The Manager leads staffing models, hiring, onboarding, and workforce optimization, and addresses high-level operational challenges including coverage, call schedules, overtime, and investigator engagement. The Manager ensures appropriate senior and supervisory coverage for complex, inpatient, and nuanced research activities. The CRM involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures, good clinical practice, and regulations. May be responsible for finances, clinical operations, and site and vendor selection. The responsibilities are broad and diverse to include personnel management, physician relations, customer service, oversight of study patient screening and enrollment, tracking of clinical trial progress, compliance with regulatory standards, and the general oversight of the research process. Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR's clinical trial portfolio. Oversees unit operations to ensure compliance with departmental or organizational policies, procedures, and defined internal controls. Ensures accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental standards and procedures. Provides guidance to Clinical Research Supervisors overseeing and coordinating a large portfolio of complex clinical studies. This individual will initiate and maintain relationships with the research community, Health Systems, clinical research staff, investigators, external companies, academic leaders, as well as organizational executives. The Clinical Research Manager will interact with all levels of management, including the Dean's Office of the School of Medicine and Office of Research, to plan, organize, lead, and monitor the scientific and clinical performance of research and ensure regulatory compliance. This individual orchestrates the long-term viability and growth of the institution's research programs by working closely with industry as well as physicians to participate in clinical trials that will benefit the community by leveraging the expertise of clinicians. The CRM serves as the liaison to sponsors, governing agencies, and facilitates transmission of verbal and written communication to national cooperative groups, pharmaceutical companies, and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. The CRM guides the Clinical Research Supervisor in their responsibility to ensure the team's adherence to protocols, appropriate management and distribution of the clinical research workload, ensuring CRC compliance with industry and federal sponsor data entry requirements, and overseeing auditing and monitoring visits. The CRM is responsible for overseeing achievement of operational goals and objectives for implementation with each Supervisor. Additionally, the incumbent is responsible for leading ongoing training and education of CRCs, liaising with all appropriate administrative and medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) managing quality assurance and quality improvement goals and objectives through audit reviews of the team's portfolio. Work is primarily on-site across clinical locations. Remote work will only be approved with authorization from the Assistant Director.QualificationsRequired:Demonstrated experience working within complex organizational structures with strict policies and parametersKnowledge of research design, research process, study budgets, and study implementationExperience with study budgets, financial management, and billing oversightProven track record of personnel management including hiring, performance management, and staff developmentAbility to effectively manage multiple priorities, prioritize projects, and meet the demands of a fast-paced and dynamic work environment; adaptable to quickly changing prioritiesDemonstrated skills in employee supervision and HR administrationDemonstrated experience in training others, particularly in the field of researchCritical thinking skills to evaluate issues and identify a potential solutionClear and concise communicator; good verbal and written communication skills with outstanding verbal and written communication skillsGood interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorshipInterpersonal skills to effectively motivate othersWorks well with others to achieve common goalsAbility to cultivate relationships with multiple stakeholders at various levels of administrationEffective oral and written communication skills with technical writing skills sufficient to compose a variety of scientific documents, reports, budgets, and justifications which are clear, concise, logical, and display syntax and grammarWorking knowledge of clinical protocol design, content, and categories for inclusion in a final documentAbility to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacyAbility to establish and maintain cooperative working relationships with external sponsors, colleagues, faculty, and staffExcellent interpersonal, organizational, and time management skillsAbility to work both independently and as part of teamAbility to take initiative and demonstrate strong commitment to dutiesAbility to act independently with demonstrated problem-solving skills, multi-task, and to follow through on assignments with minimal directionAbility to accept equivocal circumstances and take action where answers to a problem are not readily apparentAbility to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentationOrganizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrativeSkill in performing a variety of duties, often changing from one to another with frequent interruptionsSkill in composing letters, preparing documents, and facilitating the production of materialsExtensive experience with clinical research and data collection methodsAbility to work within a deadline-driven structureExperience in maintaining flexibility and adaptability while supervising and implementing institutional changeWillingness to work as a supportive, cooperative member of an interdisciplinary teamFoster and promote a positive attitude and professional appearanceStrong leadership, planning, and project management skillsThorough understanding of FDA, GCP, and ICH guidelinesThorough understanding of research compliance requirementsExpertise with Microsoft Office (Word, Excel, Outlook, PowerPoint)Access to transportation to off-site research locations; travel to Irvine campus and satellite work sites as neededBachelor's degree in related area and / or equivalent experience / trainingResearch certification (ACRP, SoCRA, or equivalent) requiredA minimum of 7 years of clinical research experiencePrevious experience leading or supervising a teamPreferred:Advanced degree preferred.Special Conditions:Some after business hours and occasional weekendsTotal RewardsIn addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.Conditions of Employment:The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:Background Check and Live ScanEmployment Misconduct*Legal Right to work in the United States