Peachtree BioResearch Solutions is a fast-growing full service CRO based in Atlanta GA with multiple remote based opportunities. Our focus has been in rare disease and CNS studies, but we partner with small and mid sized sponsors across multiple therapeutic areas. Due to growth, we are looking to add a Clinical Data Associate. This person can work either remotely or in our main Atlanta office and will be responsible for high quality data cleaning of clinical databases to facilitate analysis and reporting. This role can have a major impact on overall study timelines and quality of CDM deliverables.
- Reviewing and interpreting automated data discrepancy output, as well as performing manual listing reviews and generating data queries to be sent to the site, following standard conventions and procedures.
- Managing the data cleaning process for the study, including interpreting clinical site responses to queries and determining whether the responses are sufficient.
- Updating the clinical database with the resolution provided and determining the resolution status of the queries, for studies using paper based processes.
- Performing quality control measures to ensure the final clinical database prepared for analysis and reporting as specified in the Data Management Plan.
- Participating in system and study validation processes, including the creation and execution of validation test documentation.
- Creating trial specific documentation as needed, such as CRF Completion Guidelines, Data Entry Conventions.
- Providing support for study team and investigation site staff regarding Electronic Data Capture systems.
- Assisting in the creation of standard procedures and guidelines for Data Management activities.
- Previous clinical data management experience performing data review/cleaning activities.
- Working knowledge of medical terminology.
- Previous experience with relational databases, preferably Electronic Data Capture systems.
- Excellent knowledge of MS Office products.
- Prior experience in computer system validation, in particular FDA 21 CFR part 11, desired.
- Excellent communication, time-management, and organizational skills.
- Working knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
- Excellent communication skills, both verbal and written, of English.
- Accurately and efficiently work towards quality results.
- Must demonstrate the ability to interpret, evaluate and trouble-shoot issues pertaining to the data associate activities, in an effort to determine the appropriate actions necessary for ensuring that the tasks associated with cleaning are completed both accurately and efficiently.