DESCRIPTION

The Moores Cancer Center (MCC) is one of just 54 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 28 departments, 6 schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advanced patient care, and serving the community through outreach and education programs. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy of career-path development for its employees including opportunities for cross-training, professional development, and progressive responsibility.

MCC's mission is to transform cancer care in our catchment area and beyond by driving exceptional scientific discoveries and innovations in prevention, detection, care, and training. MCC will make a global impact on improving health by reducing cancer burden through accelerated discovery and translation, compassionate and interdisciplinary care, education and community engagement, with the foundation of our core values - Excellence, Innovation and Risk-Taking, Collaboration, Diversity and Service.

The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.

Reporting directly to the CTO Associate Director, Clinical Operations, the Network Sites Project Manager oversees the day-to day activities of Network Coordinators, including oversight and coordination of a portfolio of oncology clinical studies. The incumbent is directly responsible for ensuring the team’s adherence to protocols, appropriate management and distribution of the clinical research workload, ensuring Network Coordinator compliance with sponsor requirements and federal regulations overseeing auditing and monitoring visits.

The Network Sites Project Manager is responsible for supervising, administering, and achieving operational goals and objectives for implementation across network sites, and is directly responsible for the management of MCC CTO staff at each location. They also play a key role in 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.) at each site for the conduct of the trial, managing quality assurance and quality improvement goals and objectives.

Coordinates and oversees a clinical trial from inception through completion, including approvals, initiation (site visit coordination), protocol implementation, recruitment, screening, enrollment, data management, maintenance of subjects, writing publications and finalization of sponsor requirements. Oversees and analyzes complex databases. Compiles data reports as needed. Provides team, investigators, and clinical fellows with guidance regarding study design and logistics. Supervises staff work assignments and schedules to meet network goals and timelines. Meets regularly with assigned staff to set goals and ensure objectives are being met. Supports patient recruitment plan development and execution, in conjunction with the Office of Community Outreach and Engagement (COE) and other Marketing, Communications and Business Development functions, including leadership and clinical staff at each network site participating in oncology clinical trials. Evaluate and assess the patient population of each network site, and promote trials that address oncology health disparities for each site's surrounding community.

Work with PIs and Director to plan and implement multiple phase I, II & III studies at network sites, identify potential gaps in the clinical trial portfolio to meet patient needs at network sites. Develop programmatic efforts across network sites, including feasibility review, site selection and defining needs for resources (e.g., equipment, staffing, etc.) and training of the clinical trial protocol. Collaborate with PIs and Director to select clinical trials that meet the unique needs of each site's patient population. Independently participate in onsite study monitoring visits, demonstrating proficiency in data management practices. Provide oversight, support and education to clinical staff (e.g., investigators, nurses, coordinators, ancillary services, etc.) on Good Clinical Practice (GCP) for clinical trials.Assure timely and accurate design and submission of reports, proposals and data collection instruments (instruments includes surveys and equipment for the study), with minimal protocol deviations and mitigations against delayed data entry. In collaboration with the Quality Assurance and Compliance function, develop Quality Assurance (QA) plans to monitor network site accruals, patient safety and timely data entry, considering frequency and type of review (i.e., contemporaneous). Review findings and feedback, and oversee implementation of Corrective and Preventive Actions (CAPAs) with Network Coordinators.

MINIMUM QUALIFICATIONS

• Nine years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training.

• Clinical Trial Professional certification from a professional society within one year in position.

• Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.

• Demonstrated project management skills. 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 experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.

• Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems.

• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.

• Excellent 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.

• Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization.

• Knowledge and experience of the clinical research coordinator, clinical research data coordinator, and long-term follow-up coordinator roles.

• Experience in Clinical Trials and Clinical Trials Program Management. Hands-on experience with Industry sponsored trials, cooperative group trials, and/or investigator-initiated trials Demonstrated project management skills. 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.

• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.

• Experience developing and maintaining record management systems. Experience and ability to accurately collect, record, transcribe and synthesize clinical data.

• Knowledge of technical programs supporting recording, videotaping, and remote-meeting access, similar to Zoom and MS Teams.

• Knowledge of investigational protocols (various trial products, data gathering, phases and protocol designs). Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.

• Experience working in a clinical research environment such as CRO, academic research institution, and/or a research hospital. Experience reading and interpreting clinical trials research protocols. Administrative experience in summarizing protocol reviews, ability to format and edit minutes for the Protocol Review and Monitoring Committee.

• Strong administrative experience using standard word processing and data management software programs, including Word and Excel, to develop and prepare reports. Computer proficiency, including working knowledge of various software programs (such as Adobe Acrobat, web browsers, CTMS, Epic, REDCap, etc.) and internet browser applications. Experience in conducting searches on the internet. Ability and willingness to learn new software as needed.

• Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.

PREFERRED QUALIFICATIONS

• Advanced degree and/or SoCRA or ACRP Certification.

• Bilingual-fluent in second language.

• Knowledge or experience with oncology research and terminology.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check and pre-employment physical.