The Clinical Data Abstractor is responsible for clinical trial data abstraction from medical records and data entry into an EDC database. This individual functions as part of the Clinical Operations department team that includes Data Abstraction and Data Monitoring. Primary responsibility is to transfer data from medical records provided by the participating sites into the Electronic Data Capture system database to ensure complete and accurate chart data abstraction centrally for assigned charts.
The Clinical Data Abstractor will conduct data abstraction on a daily basis and provide feedback/queries associated with those records as necessary. The Abstractor may be asked to provide input on existing systems used to receive and track records and on data entry to ensure project efficiency and accuracy. Additionally, the employee will assist research coordinators as directed by their supervisor to clinical trial source data collection and entry needs.
Job Details/ Main Responsibilities
- Data Entry (approximately 80%)
- Reviews medical records received from sites and enters data into EDC strictly following data abstraction guidelines.
- Responds to case report form queries in timely fashion.
- Learn and implement Chart Data Abstraction Conventions to ensure accuracy of entries.
- Provides feedback on policy and procedures to limit data omissions and errors.
- Follows data abstraction deadlines et by management.
- Collaborates with research coordinators to ensure that source records provided by the sites are complete and accurate.
- Proposes new Chart Data Abstraction Conventions to streamline entry processes.
- Clinical Site Support (Approximately 10%)
- Collaborates with Clinical sites to ensure protocol required data points are submitted according to the guidelines.
- Performs filing of study visit related documents in corresponding source records as needed.
- Follows-up on patient laboratory results as necessary.
- Support other TPS research studies (Approximately 5%)
- Assists in creating study source worksheets for new studies reflecting all protocol required elements.
- Assist regulatory specialist with filing and copying.
- Other Special training and assignments (Approximately 5%)
- Receives a variety of routine trainings on an annual basis to ensure safe and proper functioning of the laboratory and patient data management. Trainings must be complete within the time lines established by entities within the department or as specified by funding institutions.
- Participates in team meetings/ discussions as requested.
Education and Experience
High school diploma required. Clinical trial data entry experience is preferred. Experience with multiple databases (REDCap, INFORM, RAVE, TAO) etc is preferred.
Applicants must be authorized to work in the United States without sponsorship. This position is only considering candidates that can work out of our Durham, NC office.