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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 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 related to the organization’s clinical research trials. Responsibilities
Review and process research charts for accuracy and completeness. Electronic data capture completion (EDC). Quality control of EDC. 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 retrieves the information from the research team to assess for completeness, accuracy and errors. 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. Become familiar with current International Conference on Harmonisation Good Clinical Practice (ICH GCP) best practices and guidelines. Requirements
Must be flexible with a positive attitude and a strong work ethic. Works quickly and goes beyond the call of duty. Strong computer skills with MS Office and ability to learn new software. Ability to use various databases. Critical thinking and analytical skills. Must be able to work in a fast‑paced environment while maintaining strong attention to detail and the ability to multitask. Travel Requirements
Occasional travel may be required (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 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 whole hand or arm. Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed accurately, loudly, or quickly. Hearing: Perceiving the nature of sounds at normal speaking levels; receiving detailed information through oral communication and making fine discriminations in sound. Visual acuity: Close visual acuity to perform activities such as preparing and analyzing data, transcribing, viewing a computer terminal, extensive reading, visual inspection involving small defects, small parts, and/or operation of machines; using measurement devices and/or assembling or fabricating parts at close distances.
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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 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 related to the organization’s clinical research trials. Responsibilities
Review and process research charts for accuracy and completeness. Electronic data capture completion (EDC). Quality control of EDC. 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 retrieves the information from the research team to assess for completeness, accuracy and errors. 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. Become familiar with current International Conference on Harmonisation Good Clinical Practice (ICH GCP) best practices and guidelines. Requirements
Must be flexible with a positive attitude and a strong work ethic. Works quickly and goes beyond the call of duty. Strong computer skills with MS Office and ability to learn new software. Ability to use various databases. Critical thinking and analytical skills. Must be able to work in a fast‑paced environment while maintaining strong attention to detail and the ability to multitask. Travel Requirements
Occasional travel may be required (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 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 whole hand or arm. Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed accurately, loudly, or quickly. Hearing: Perceiving the nature of sounds at normal speaking levels; receiving detailed information through oral communication and making fine discriminations in sound. Visual acuity: Close visual acuity to perform activities such as preparing and analyzing data, transcribing, viewing a computer terminal, extensive reading, visual inspection involving small defects, small parts, and/or operation of machines; using measurement devices and/or assembling or fabricating parts at close distances.
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