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 to the Network Sites Project Manager, the Network Coordinator II is responsible for coordinating and monitoring clinical trials including providing all aspects of protocol oversight, including but not limited to screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug/therapy reaction reports, monitoring patient treatment and toxicities, laboratory and specimen collection, processing, and submission, and maintenance of accurate and complete clinical research files.

Coordinate development of cooperative group affiliation including credentialing, data entry support, and coordination of training. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Oversee research protocol writing, start-up procedures, implementation, recruitment, and close out procedures. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards as assigned. Provide direct assistance to the Research Director in reviewing and verifying research account statements, professional fee statements, and invoicing. Coordinate research efforts with the Moores Cancer Center team through close communication and collaboration with the Associate Administrative Director and Administrative Director.

Act as a liaison with other departments and community clinics / agencies for the purpose of implementation of studies. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Work closely with federal and state regulatory officials.

MINIMUM QUALIFICATIONS

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

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Demonstrated experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect, process, and ship specimens, and orient participating physicians.

• Experience in medical assessment and patient interviewing to determine toxicities related toprotocol management. Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

• Experience interpreting medical charts and abstracting data from medical records.

• Thorough knowledge of experimental protocols, data gathering, protocol design and evaluation.

• Strong knowledge of investigational protocols especially with radiation oncology protocols (data management, query resolution, protocol design, protocol writing, evaluation, and protocol implementation). Working knowledge of medical and scientific terminology.

• Strong experience completing clinical trials case report forms via hard copy and online.

• Strong experience in clinical trials research.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Experience working with FDA policies regulating clinical trials.

• Proven ability to problem solve and resolve conflict.

• Meticulous attention to detail.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• Computer proficiency, including working knowledge of word processing, spreadsheet software(Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to useindependent judgment to organize and prioritize office functions.

• Ability to function independently under general supervision.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

PREFERRED QUALIFICATIONS

• Master's degree in a social science or basic science such as Biology, Microbiology or a related field.

• Certification as a Clinical Research Coordinator.

• Fluent in English and at least one of the following languages: Spanish, Tagalog, Korean, Vietnamese, Arabic, Mandarin or Cantonese.

• Knowledge of hematology/oncology or radiation oncology. Ability to differentiate various cancers by stage, histology, and site to determine patient eligibility for protocols and assure accurate randomization.

SPECIAL CONDITIONS

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

• Must be able to travel to different locations and work weekends and eveningsas needed.