Data Entry Specialist

Data Entry SpecialistSan Antonio, United States of America | Full time | Home-basedUnder the direction and supervision of the Director of Data Management, this position is responsible for performing all data entry functions as they relate to the completion of case report forms, by entering study data collected by the research team into the Electronic Data Capture (EDC) system. Data entry personnel will also resolve all data queries. The position works closely with the research coordinators in support of all ongoing clinical studies.Essential Duties and ResponsibilitiesOversee and manage the data entry from the source document to the case report form (CRF)Reviews patient records for completeness and accuracyMeets with sponsor/monitors to review data entryServes as a backup to help coordinate and schedule monitoring visitsServes as a backup to provide support and information to monitors as necessary and as directed by supervisor(s)Timely resolution of data queries promptly to insure completeness of CRFsAssures that data entry remains current for all studies per SOPComplies with all applicable regulations, guidelines and procedures pertaining to dataloading, EDC and clinical researchIdentifies lab facilities used for studies so that lab certifications can be requested for study filesReviews and utilizes protocols as guides for study activitiesCommunicates as needed with accounts receivable staff regarding submitted dataAttends meetings and briefings regarding clinical studies as requiredAbility to assist in the guidance and training of less experienced staffAbility to maintain a positive attitude with the research teamMaintain professional demeanor with sponsors, monitors, and auditorsRemains current with all required trainingPerforms other duties as assignedKnowledge, Skills and AbilitiesWorking knowledge of clinical research Electronic Data Capture (EDC) systemsExcellent interpersonal skills to deal effectively with research personnelKnowledge of medical terminologyKnowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical researchExcellent organizational skills to independently manage workflowAbility to prioritize quickly and appropriately with minimal guidanceAbility to multi-taskAbility to work independently and function as part of a teamClear and concise verbal and written communicationsRequired Education and ExperienceHigh School Diploma, Associate Degree and/or certificate program preferred