Research Data Coordinator

Job Summary

This position is primarily a study lead Clinical Data Manager. It supports multiple clinical study teams by reviewing and/or completing study related clinical data management deliverables. Frequently interacts with study team members to troubleshoot, manage, and develop study specific processes. Actively participates in the development of processes, and documents, that support the clinical data management team.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Responsibilities

1. Participate in the cross-functional project teams as the lead clinical data manager.
2. Provide input in the design of protocols, forms, and data collection processes.
3. Create and maintain the following study specific documents: Data Management Plans, Edit specifications, SAE Reconciliation Guidelines, Other plans and guidelines as required.
4. Ensure documents are provided according to established timelines and SOPs.
5. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.
6. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.
7. Review and provide feedback on other study specific documents.
8. Manage all data management activities of a clinical trial in the maintenance phase of the project.
9. Provide project specific training on electronic data capture (EDC) and other data management systems to internal and external personnel.

Minimum Qualifications

Bachelor's degree in the life sciences, pharmacy, nursing, a related subject, or equivalency. Requires two or more years of relevant clinical data management experience. Understanding of basic regulations involving clinical trials, clinical data management, and clinical data systems.