Department of Pediatrics is one of the largest departments within the UCSD School of Medicine with comprehensive clinical programs, extensive basic science and clinical research, and diverse educational opportunities for students, residents and fellows. The internationally renowned faculty play a major role in medical and graduate student training, providing educational and programmatic offerings that span several disciplines and provide diversity to meet the interests of a broad spectrum of students and scholars. More than one hundred trainees at the graduate student and postdoctoral level, as well as more than 300 professional, research and administrative staff who along with the department administrators interact closely with the faculty. The diverse mix of ages, backgrounds, and talents creates a robust work environment with challenging career opportunities and a commitment to continued growth potential. We constantly seek to recruit highly motivated, technologically-advanced and interested individuals to become a part of our dynamic cutting-edge research, clinical, and educational environment.

Under the Direction of the CHAT Consortium Chair and Medical Director and the guidance of the Clinical Research Manager, the Clinical Research Analyst 4 will independently oversee complex database building and data management activities for CHAT Consortium studies. Applies extensive knowledge as a research professional with an in-depth understanding of FDA 21 CFR Part 11 guidelines for clinical research. Develops, implements, and maintains database systems for the data collection, manipulation, transfer, storage, and analysis and/or oversees and coordinates these with external Data Coordinating Center. Specializes in clinical research studies in all study phases and monitoring. Develops Data Management Plans for CHAT protocols of varying complexity and scope. Provides guidance to research faculty, staff, and students on moderate statistical issues. Responsible for overall program adherence to research data security measures and implementing data integrity measures. Performs routine maintenance and backup for sensitive data, lead quality assurance (QA) initiatives.

Coordinates with personnel at multiple clinical trial sites, collaborating Data Coordinating Center and laboratories, partner CHAT sites and industry sponsors on data management activities. As the data expert for the CHAT CoM nsortium, the incumbent will track, analyze and report on program metrics, producing elegant and powerful data visualizations for leader meetings and award reports. Develops and maintains systems for the continued optimization of the entire spectrum of clinical research programs, safety monitoring activities and patient registries. Works with institutional data systems (example: VELOS, RedCap, EPIC) and data retrieval methods across the several platforms, recommending improvements of data collections processes.

As the technical lead of the study team, the incumbent will leverage leadership experience and expertise to make innovative contributions to clinical studies including design of protocols (what and how data is to be collected); design and review of Case Report forms (CRFs); database design (ensuring design meets requirements for entry and reporting of clinical data), as well as summaries and listings of data; tests new processes and systems for the management of CHAT Consortium supported clinical trials, conducts training of study teams for all CHAT study EDCs and CRFs, and manages efforts in data cleanup and auditing. The Research Data Analyst 4 will mentor and train research team personnel regarding data coding, entry, quality assurance, compliance and management in the design and implementation of databases for clinical research studies and produces Electronic Data Capture (EDC) system and (CRFs) user manuals for CHAT studies.

Oversees regulatory compliance for all CHAT studies and participating sites including developing and maintaining study tools and forms, study manuals, participates in Site Initiation Visits and ensures sites meet regulatory requirements prior to activating sites on a study, and conducts remote monitoring visits when required.

Applies extensive knowledge as a research professional with an in-depth understanding of statistical and / orother analysis techniques designed to support research projects of broad scope and complexity. Functions asa team lead. Performs other duties as assigned.

• Nine (9) years of related experience, education/training, OR a Bachelor's degree in related area plus five (5) years of related experience/training.

• In-depth knowledge of research function.

• Advanced skills associated with statistical analysis, database management and systems programming. Demonstrated sophisticated knowledge of statistical computer packages, including R and SAS.

• Advanced skills in analysis and consultation. Ability to lead and influence within and external to project team. Ability to recommend plans for research design and study development.

• Advanced ability to communicate complex information in a clear and concise manner both verbally and in writing.

• Advanced project management skills. Ability to lead and influence within and external to project team.

• Advanced research skills at a level to evaluate alternate solutions and develop recommendations.

• Advanced ability to think creatively to recommend action steps or strategize solutions relative to research.

• Theoretical knowledge in life, biological, or physical science, e.g. Biostatistics and Bioinformatics, preferably at the Master's level, or equivalent combination of education and experience.

• Proficient in methods of data collection, analysis, and management of a study center involving multiple large and complex research projects or studies. Knowledge of descriptive reporting on study accrual, adverse events and outcomes. Demonstrated experience in databases design, development, management, and usage. Understanding of relational and object oriented databases, data and file types, and user interface design.

• Demonstrated experience in clinical research trials and clinical trial protocol development and implementation. Knowledge of clinical trial components including statistics, study methodology, informed consent, eligibility, and adverse events. Demonstrated success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols. Experience with regulatory issues in clinical research.

• Experience in clinical data management and Electronic Data Capture (EDC) systems.

• Experience and knowledge with medical terminology, medications and research terminology, and standards including medDRA, WHO Drug, and CDISC.

• Demonstrated knowledge of 21 CFR Part 11 and GCP with solid experience in clinical research.

• Excellent organizational and problem solving skills. Strong attention to detail but ability to plan for long-term contingencies.

• Demonstrated experience in clinical research methodology and terminology to inform the development and review of research database and data management.

• Proven ability to research, gather and organize information to produce clear and concise reports and presentations using various resources.

• Strong computer skills and demonstrated knowledge of a variety of software programs (email, word processing, spreadsheet, database applications, Adobe Acrobat, web browsers, etc.) Ability and willingness to learn new software as needed.

• Five (5) years or more of hospital based clinical research experience within an academic medical center.

• Knowledge and understanding of regulatory compliance including FDA Guidelines (ICH, GCP), Institutional Review Board and Human Subject Research and institutional policies and SOPs.

• Three (3) or more years of clinical trials protocol and case report form development.

• Three (3) or more years of clinical data management.

• Knowledge of UCSD policies and procedures.

• Employment is subject to a criminal background check.