Hemispherx Bio Pharma, Inc Work Values

Daily Duties at Hemispherx Bio Pharma, Inc:

-Led in the design of Case Report Forms, using MS Office 2003, for five clinical (primarily HIV and Chronic Fatigue Syndrome) and laboratory study trials (other studies were cancer, hepatitis, severe burns, Phase I to Phase III trials). -Coordinated the annotation of CRFs using SAS conventions for tables and labeling fields (same for EDC). -Transformed CRFs into database using data management system ClinAccess Powered by SAS. -Initiated test practices for databases with set procedures and guidelines. -Designed and transformed legacy data and homegrown databases to SAS conventions and reengineered past reports, statistics, and graphics. -Oversaw and coordinated specs for data entry. -Initiated and coordinated the Data Plan. -Coordinate edit checks and supervised the review processes for query reporting. -Coordinate verification of clinical data, laboratory results and QoL data points for completeness and accuracy. -Transformed and analyze Quality of life questionnaire test score data and providing summary statistics to the biostatistician. -Designed and maintained spreadsheets for tracking baseline and end of study endpoints for the efficacy and safety of data, as per Protocol. -Designed and maintained spreadsheets for tracking patients throughout the study. -Initiated drug accountability reports. -Initiated verification set procedures and validation of database. -Initiated coding SAEs and AEs in COSTART and MedDRA. -Participated and oversaw closeout. -Coordinated and updating departmental SOPs for both Data Management and Clinical. -Initiated documentations and written procedures related to data management activities. -Designed and Transformed clinical data, for the Medical Director, into test slides, graphics, summary charts, abstracts, for publishing in the medical journals, medical conferences, conventions and corporate meetings. -Launched inventory of company’s' owned Patents and Applications for payments and renewals. CRA -Help coordinate team initiation process for each site by designing source notes (based on CRFs), instructions for completing CRFs and setup Regulatory binders. -Initiated and provided support to the Project Manager to go on monitoring visits to inspect the facilities, review CRFs for completeness against source notes and/or medical records. -Verify SAEs and AEs. -Transacted all questions and concerns site may have about the Protocol specs. -Provided summary reports, to the Project Manger, of my findings at each site visit and follow-up to resolution. -Assisted and prepared closeout procedures at sites. -Review Regulatory documents are current for FDA inspection.

What they like about Hemispherx Bio Pharma, Inc:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

Tags

Database Design, Clinica Research Associate, Document Specialist, SAS basic, Data Entry, Clinical Data, Data Manager, Clinical Data Analyst/Reviewer, Clinical Reviewer, ClinAccess Powered by SAS 4.2

Skills

P&L responsibilities, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership , Database design, Design Forms, Experienced in documentation, Coding AEs, Testing software

These are some of the questions we asked our climbers about their experiences with Hemispherx Bio Pharma, Inc: