Clinical Database Associate
The Clinical Database Associate will collaboratively support Clinical Affairs, and external vendors to ensure that clinical data is collected, managed, and organized in a timely manner that adheres to strict clinical policy. This position will wear many hats and work collaboratively and cross-functionally with many departments within Pulse.
Essential Duties and Responsibilities
- Create and test study data collection modules (e.g., CRFs, databases, etc).
- Create study annotations and data listings.
- Develop scripts to maintain and resolve database issues.
- Review and validate data verification.
- Enter study data into appropriate databases.
- Design, build, and conduct edit checks against data.
- Execute and review the results of data verification and cleaning scripts.
- Review, query, and resolve outstanding data entry issues.
- Work with CRAs and site coordinators on study data issues.
- Develop and execute UATs.
- Complete EDC guidelines for sites.
- Develop and implement customer-defined study closeout procedures.
- Assist in the development of data standards and workflows for Data Management department.
- Attend data management meetings and share work progress.
- Prepares periodic and specialized data reports and data listing.
- Manage user accounts.
- Trains sites on how to use EDC.
- Other duties as assigned.
Education and Experience
- Bachelor's Degree in Clinical, Clinical Data, IT, or related field.
- 3+ years' experience in clinical data.
- GCP certificate highly desired .
Skills, Abilities, and Other Requirements
- Proficient knowledge of:
- MS Office Suite applications
- Clinical Data Collection
- IT and Systems Integration
- Windows OS
- Excellent oral written communication skills and critical thinking skills.
- Ability to work well independently (self-starter) and as part of a team and adaptable
- Ability to take direction and execute accordingly
- Ability to articulate technical challenges internally and to external study-related personnel
- Excellent organizational, analytical and debugging skills
- Must be able to review and understand medical/technical data
- Ability to give and receive feedback