clinical Research Manager

Position Summary

• The Clinical Research Manager (CRM) reports to, and is directly responsible to, the Assistant Director, Clinical Trials Unit for all clinical research matters fulfilling the mission of the Chao Family Comprehensive Cancer Center (CFCCC), the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise.
• The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine.
• The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients. 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 incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance 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 Assistant 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 CRM 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.

• Bachelor's degree in related area.
• Clinical Trial Professional certification from a professional society within one year in position.
• 5 - 7 years of experience with BA/BS or equivalent years of relevant experience in an academic and/or research environment • Nationally-recognized clinical research coordinator certification (e.g., Society of Clinical Research Associates [SOCRA], Association of Clinical Research Professionals [ACRP], etc.)
• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters • Demonstrated experience supervising staff in research environment.
• 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.
• Access to transportation to off-site research locations.
• 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).

• Advanced degree preferred

Required

• 5 - 7 years of experience with BA/BS or equivalent years of relevant experience in an academic and/or research environment.
• Nationally-recognized clinical research coordinator certification (e.g., Society of Clinical Research Associates [SOCRA], Association of Clinical Research Professionals [ACRP], etc.).
• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters • Demonstrated experience supervising staff in research environment.
• 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.
• Access to transportation to off-site research locations.
• 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).
• Preferred: Experience at a NCI-designated Comprehensive Cancer Center.
• Extensive experience with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored.
• Experience with clinical trial management systems, preferably OnCore 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; both. 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.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.