Job ID: 90761
Job date: 2017-11-02
End Date:
Company : UC San Diego Country : Role : Research Scientist
Job date: 2017-11-02
End Date:
Company : UC San Diego Country : Role : Research Scientist
Job Description:
As a key member of a multidisciplinary team, the Clinical Research Data Analyst will oversee data management and analysis activities to support research projects of the CIRM UCSD Stem Cell Alpha Clinic and Principal Investigators that is expected to include 3-15 concurrent clinical trials. This position will be responsible for application of a broad range of reporting and statistical analysis. From project start-up to database lock, the incumbent is responsible for assisting protocol development and specifically a statistical analysis plan. During the study the person will be responsible for monitoring clinical trial data for completeness, accuracy and consistency, ensuring data meets the quality standards expected for reporting to regulatory bodies. This includes, but is not limited to, identifying more efficient methods of data collection, flow, error correction, and reporting. Frequent interaction and coordination with technical personnel at the clinical trial site and collaborating laboratories and sponsors will be required. On completion of studies the data closeout and final statistical analyses will be a function of this position with assistance in dissemination of results through manuscripts and other presentations. As the technical lead of the study team will make innovative contributions to the clinical studies including design of protocols; design and review of electronic Case Report forms; database design (ensuring design meets requirements for reporting and analysis of clinical data); produce summaries and listings of data; test new processes and systems for the management of Alpha Clinic clinical trials, and lead efforts in data clean-up and auditing. Should be proficient in methods of data collection and analysis including descriptive reporting on study accrual, adverse events and outcomes. Provides coaching, support and mentoring to less experienced team members in data coding, entry, quality assurance/compliance and management, and in the design and implementation of clinical databases for clinical studies. Will oversee routine maintenance and backup for sensitive data, design quality assurance (QA) programs to verify data entry, ensure data accuracy, and generate and distribute queries to study sites to verify incorrect or missing data. This position would benefit from web programming experience, experience with clinical research database interfaces and statistical methods for phase 1-3 clinical trials. Experience in bioinformatics would be advantageous but not required. Should be proficient in execution of basic statistical tests with preference for some abilities in modeling methods such as logistic regression, generalized linear models, mixed effects models, power and sample size calculations. Bioinformatic methods would refer to genomics and sequence analysis using generation sequencing platforms. MINIMUM QUALIFICATIONS:
Additional Info:
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.[Click Here to Access the Original Job Post]
As a key member of a multidisciplinary team, the Clinical Research Data Analyst will oversee data management and analysis activities to support research projects of the CIRM UCSD Stem Cell Alpha Clinic and Principal Investigators that is expected to include 3-15 concurrent clinical trials. This position will be responsible for application of a broad range of reporting and statistical analysis. From project start-up to database lock, the incumbent is responsible for assisting protocol development and specifically a statistical analysis plan. During the study the person will be responsible for monitoring clinical trial data for completeness, accuracy and consistency, ensuring data meets the quality standards expected for reporting to regulatory bodies. This includes, but is not limited to, identifying more efficient methods of data collection, flow, error correction, and reporting. Frequent interaction and coordination with technical personnel at the clinical trial site and collaborating laboratories and sponsors will be required. On completion of studies the data closeout and final statistical analyses will be a function of this position with assistance in dissemination of results through manuscripts and other presentations. As the technical lead of the study team will make innovative contributions to the clinical studies including design of protocols; design and review of electronic Case Report forms; database design (ensuring design meets requirements for reporting and analysis of clinical data); produce summaries and listings of data; test new processes and systems for the management of Alpha Clinic clinical trials, and lead efforts in data clean-up and auditing. Should be proficient in methods of data collection and analysis including descriptive reporting on study accrual, adverse events and outcomes. Provides coaching, support and mentoring to less experienced team members in data coding, entry, quality assurance/compliance and management, and in the design and implementation of clinical databases for clinical studies. Will oversee routine maintenance and backup for sensitive data, design quality assurance (QA) programs to verify data entry, ensure data accuracy, and generate and distribute queries to study sites to verify incorrect or missing data. This position would benefit from web programming experience, experience with clinical research database interfaces and statistical methods for phase 1-3 clinical trials. Experience in bioinformatics would be advantageous but not required. Should be proficient in execution of basic statistical tests with preference for some abilities in modeling methods such as logistic regression, generalized linear models, mixed effects models, power and sample size calculations. Bioinformatic methods would refer to genomics and sequence analysis using generation sequencing platforms. MINIMUM QUALIFICATIONS:
- 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.
- Exceptional analytical skills with demonstrated skill and ability in evaluating quality of research data and preparation of summary reports.
- Demonstrated skill in fundamental statistical analysis. Ability to develop utilities to assist with data reporting, monthly accrual monitoring and tracking of subjects. Proficient in execution of basic to moderately complex statistical tests.
- Experience and knowledge with medical terminology, medications and research terminology, and standards including medDRA, WHO Drug, and CDISC.
- Demonstrated experience in clinical research methodology and terminology to inform the development and review of research database and data management.
- Experience in Phase I Clinical Trials.
- Knowledge of UCSD policies and procedures.
- Experience in modeling methods such as logistic regression, generalized linear models, mixed effects models, power and sample size calculations, statistical methods for genomics and sequence analysis including next generation sequencing platforms.
- Employment is subject to a criminal background check
- This position involves research that uses human Embryonic Stem Cells. This is not a laboratory or clinical position, but working near labs and clinics where biological, chemical, and radiation hazards are present and animals and human embryonic stem cells are used in research may be required.
Requeriments :
Skills :
Additional Info:
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team! Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached. UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.[Click Here to Access the Original Job Post]