Kriger Research Center
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CLINICAL RESEARCH DATA MANAGEMENT, ANALYSIS,ICH/GCP & COURSE
For starting Dates Please Call (416) 630-0038 (in Canada) Tel: 1-866-757-9791 (USA)
Clinical research Data Management , Analysis , ICH/GCP Course is a summary of the duties and responsibilities of Clinical Data Analysts, Biostatisticians, SAS Programmers and Coding Specialists. This course is designed for foreign-trained statisticians, science teachers, data Base specialists, physicians, pharmacists, biologists, biochemists, microbiologists, nurses, and SAS Programmers who want to enter the Clinical Research field. The course begins by exploring the fundamental and proven techniques of Clinical Trials Processes, Collection, Management and Reporting of Clinical Study Data. This comprehensive course provides the essentials of understanding the roles and responsibilities of Clinical Data Analysts, Biostatisticians, SAS Programmers, and Coding Specialists. Followed by discussion of related Good Clinical Practices and FDA Guidelines for overall compliance. Additional details will be given on allocation of Clinical Trials staff members to projects. Attendees will develop communication and negotiation skills that will enhance the success of their employment. By the end of this course applicants will gain the knowledge they need to start a new career in the pharmaceutical industry. You will receive frequent mailings of the KRC Inc. Newsletter including fresh positions in the field of this course. Also you can get help in your resume preparation. As a participant of this program you are encouraged to volunteer for Kriger Research Center Research projects. This would enable you to earn appropriate experience. Clinical Trials Data Management graduates practical tasks in volunteer projects description includes: development of Clinical Trial Data Management Plans; maintaining logical, consistent and complete Data; Expert knowledge of ICH GCP; reviewing data for inconsistencies and logical errors according to the Data Management Plan; creation and manipulation of clinical databases in a variety of platforms; data analysis and preliminary presentation of results; developing, testing, documenting and maintaining clinicalresearch databases and application programs; work with Clinical team to identify protocol violations and deviations; establishment and maintenance of high standards of database administration including database validation, coding, double data entry, data validation, query management, safety reconciliation, database import/export/transfer and database lock audit; supervision of data entry activities; coding of adverse events and concomitant medications using the appropriate dictionaries specified by each project; testing and validation of data entry screens, database modules, and edit checks in the Oracle Clinical database; reviewing data queries prepared for study sites; preparing data management updates for clients; preparing data listings. The volunteer experience also provides: solid understanding of statistical analysis and quality control processes; high capabilities in both SAS programming and clinical research data management; familiarity with electronic CRF's and excellent time management, interpersonal and communication skills .CLINICAL RESEARCH PHASE 4, POST MARKET SURVEILLANCE PROJECT: All graduates tasks description includes: contacting patients randomized in research projects in order to perform personal in-depth interviews and other communications with patients and medical professionalsand contacting potential research sites and dealing with potential investigators. Some tasks have covered collecting data for PU-P 001-03 , CR-P 001-03 ,PU-C 002-03 and CR-C 002-03 forms in full scale research project "Proper Use and Cost Reduction Strategies for Prescription and Non-Prescription Drugs in Ontario" and logging data on the computer by using appropriate coding patterns along with data analyses.
Click for registration, or call the training department:
Tel: (416) 630-0038 (CANADA & Int'l)
Tel: (866) 757-9791 (USA)Fax: (416) 630-0129 (CANADA & Int'l)
Fax: (866) 757-9792 (USA)
