Clinical Research Manager

University of California, Irvine • Orange, CA

172d

About The Position

Under the general direction of the Asst. Director of Clinical Research Operations in the School of Medicine – Center for Clinical Research (CCR), The Clinical Research Manager (CRM) is responsible for all clinical research matters in fulfilling the mission of CCR under the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR’s clinical trial portfolio. The CRM serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The CRM 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 supervises the day-to day management of a team of Clinical Research Coordinators (CRCs), Assistant Clinical Research Coordinators and Research Data Coordinators overseeing and coordinating a large portfolio of complex oncology clinical studies. The CRM is directly responsible for ensuring 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 supervising, administering, and achieving operational goals and objectives for implementation within his/her specific team. The CRS is directly responsible for the management of staff. The supervisory role is composed of staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and all other HR-related functions. Additionally, the incumbent is responsible for leading on-going training and education of CRCs, leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial, managing quality assurance and quality improvement goals and objectives through routine audit reviews of the team’s portfolio.

Requirements

• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
• Critical thinking skills to evaluate issues and identify a potential solution.
• Clear and concise communicator; good verbal and written communication skills.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Effective 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 grammar.
• Working knowledge of clinical protocol design, content and categories for inclusion in a final document.
• Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy.
• Ability to establish and maintain cooperative working relationships with external sponsors, colleagues, faculty and staff.
• Excellent interpersonal, organizational and time management skills. Ability to work both independently and as part of team. Ability to take initiative and demonstrate strong commitment to duties.
• Ability to act independently with demonstrated problem-solving skills, multi-task and to follow through on assignments with minimal direction.
• Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent. Ability to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentation.
• Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative. Skill in performing a variety of duties, often changing from one to another with frequent interruptions. Skill in composing letters, preparing documents, and facilitating the production of materials. Extensive experience with clinical research and data collection methods.
• Ability to work within a deadline-driven structure. Experience in maintaining flexibility and adaptability while supervising and implementing institutional change. Willingness to work as a supportive, cooperative member of an interdisciplinary team. Foster and promote a positive attitude and professional appearance.
• Expertise with Microsoft Office (Word, Excel, Outlook, Powerpoint).
• Bachelor's degree in related area.
• 5 - 7 years of experience with BA/BS or equivalent years of relevant experience in an academic and/or research environment.

Nice To Haves

• Advanced degree preferred.
• SoCRA/ACRP certification preferred.

Responsibilities

• Responsible for all clinical research matters in fulfilling the mission of CCR under the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise.
• Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCR’s clinical trial portfolio.
• Serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed.
• 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.
• Supervises the day-to day management of a team of Clinical Research Coordinators (CRCs), Assistant Clinical Research Coordinators and Research Data Coordinators overseeing and coordinating a large portfolio of complex oncology clinical studies.
• Directly responsible for ensuring 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.
• Responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific team.
• Directly responsible for the management of staff.
• Responsible for leading on-going training and education of CRCs, leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial, managing quality assurance and quality improvement goals and objectives through routine audit reviews of the team’s portfolio.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees