Job Descriptions:-
The data entry specialist/patient safety call specialist will work with computerized and paper patient records as well as clinical trial data to ensure it is updated by the patients in a timely manner. If data is missing, the data entry specialist will contact patients to ensure their information is entered according to the study parameters. This position is responsible for performing all data entry functions as related to the organizations clinical research trials.
Responsibilities:
EDC Completion
Review and process research charts for accuracy and completeness.
Electronic data capture completion (EDC).
Quality control of EDC
Source Data Verification
Gather data from multiple source documents and enter into electronic database system.
Address data queries and make data-related corrections as needed.
May have access to sensitive patient information, maintaining the integrity of the records is a very important responsibility.
Query Resolution
If a record requires more investigation, associate will retrieve the information from the research team to assess for completeness, accuracy and errors.
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Administrative Support
Conduct safety calls with patients currently enrolled in a study.
Escort patients to and from exam rooms. Ensure they are attended to and in the right place at the right time.
Work with other team members to meet the appropriate timelines for data entry and cleaning timelines.
Required to become familiar with current International Conference of Harmonization Good Clinical Practice (ICH GCP) best practices and guidelines.
Requirements
Must be flexible with a positive attitude and a strong work ethic.
This position requires an individual who works quickly and goes beyond the call of duty.
Strong computer skills with MS office and ability to learn new software.
Data Management experience preferred.
Ability to use various databases.
Critical thinking and analytical skills.
Must be able to work in a fast-paced environment while having strong attention to detail and the ability to multitask.
Travel Requirements
Occasional travel may be required in this position (less than 2 weeks per year)
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer.
Walking; the person in this position needs to frequently be able to move about inside the office to escort patients, access file cabinets, office machinery, etc.
Must be able to lift 15 pounds at times.
Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.