We are looking for a Clinical Research Data Coordinator ready to take the next step in their career and move away from direct patient care. Our team is expanding and we are looking for someone who is able to support data management in Oncology clinical trials. This role is onsite but offers a ton of room for growth from a career perspective.
- Data Management:
- Collect, manage, and validate clinical trial data from multiple sources (eg, case report forms, electronic data capture systems).
- Ensure that all data is accurate, complete, and entered into appropriate systems in a timely manner.
- Monitor data for discrepancies and collaborate with clinical research staff to resolve issues.
- Assist in the preparation of data for statistical analysis.
- Study Documentation:
- Maintain and organize study documents, ensuring all files are current and compliant with regulatory standards.
- Ensure that all regulatory paperwork (eg, informed consent, IRB approvals) is up-to-date and available for audits.
- Track and maintain study timelines and deliverables.
- Compliance & Quality Control:
- Review data for quality assurance, ensuring adherence to study protocols and Good Clinical Practice (GCP) guidelines.
- Assist in preparing for site visits and audits by regulatory agencies, ensuring all data and documentation are in order.
- Help ensure that all regulatory requirements, including ethical and privacy standards, are met in all stages of the clinical trial.
- Collaboration & Communication:
- Work closely with Principal Investigators, clinical research coordinators, and other team members to support study activities.
- Communicate with external stakeholders, including CROs, sponsors, and regulatory bodies, to ensure smooth data flow.
- Prepare periodic reports on study progress, including data collection status and any issues or discrepancies encountered.
Must Haves
- 2-3 years in Clinical Research data management at the site level.
- Bachelor's degree is preferred.
- EDC/CTMS experience required.