Clinical Research Coordinator II

Overview

The Moores Cancer Center (MCC) is one of 57 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 UCSD and other institutions, including 28 departments and six schools, UCSD Health oncology hospitals and clinics, San Diego State University (SDSU), and the La Jolla Institute of Immunology (LJI).

These programs and units are dedicated to fulfilling the MCC mission of reducing cancer’s burden. The center offers challenging career opportunities in a fast-paced and innovative environment and supports career-path development, cross-training, professional development, and progressive responsibility. The Clinical Trials Office (CTO) at UCSDs 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.

The Clinical Research Coordinator (CRC) II will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. The CRC II will plan, develop and implement start-up procedures for multiple phase I-III research studies in the assigned disease team, as well as lead, direct, and coordinate operational efforts.

Ensure 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 ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials.

• 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 clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

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

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Strong knowledge of investigational protocols especially with oncology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).

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

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

• 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.

• Working knowledge of medical and scientific terminology.

• Proven ability to problem solve and resolve conflict.

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

• 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 use independent judgment to organize and prioritize office functions.

• Master's degree in a social science or basic science such as Biology,…