Data Entry Specialist

IQVIA•San Antonio, TX

19h

About The Position

Under 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 Responsibilities Essential and other important responsibilities and duties may include but are not limited to the following: Oversee and manage the data entry from the source document to the case report form(CRF) Reviews patient records for completeness and accuracy Meets with sponsor/monitors to review data entry Serves as a backup to help coordinate and schedule monitoring visits Serves 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 CRFs Assures that data entry remains current for all studies per SOP Complies with all applicable regulations, guidelines and procedures pertaining to dataloading, EDC and clinical research Identifies lab facilities used for studies so that lab certifications can be requested for study files Reviews and utilizes protocols as guides for study activities Communicates as needed with accounts receivable staff regarding submitted data Attends meetings and briefings regarding clinical studies as required Ability to assist in the guidance and training of less experienced staff Ability to maintain a positive attitude with the research team Maintain professional demeanor with sponsors, monitors, and auditors Remains current with all required training Performs other duties as assigned

Requirements

Working knowledge of clinical research
Electronic Data Capture (EDC) systems
Excellent interpersonal skills to deal effectively with research personnel
Knowledge of medical terminology
Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research
Excellent organizational skills to independently manage workflow
Ability to prioritize quickly and appropriately with minimal guidance
Ability to multi-task
Ability to work independently and function as part of a team
Clear and concise verbal and written communications
High School Diploma, Associate Degree and/or certificate program preferred

Responsibilities

Oversee and manage the data entry from the source document to the case report form(CRF)
Reviews patient records for completeness and accuracy
Meets with sponsor/monitors to review data entry
Serves as a backup to help coordinate and schedule monitoring visits
Serves 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 CRFs
Assures that data entry remains current for all studies per SOP
Complies with all applicable regulations, guidelines and procedures pertaining to dataloading, EDC and clinical research
Identifies lab facilities used for studies so that lab certifications can be requested for study files
Reviews and utilizes protocols as guides for study activities
Communicates as needed with accounts receivable staff regarding submitted data
Attends meetings and briefings regarding clinical studies as required
Ability to assist in the guidance and training of less experienced staff
Ability to maintain a positive attitude with the research team
Maintain professional demeanor with sponsors, monitors, and auditors
Remains current with all required training
Performs other duties as assigned