Research Coordinator
5 days ago
We are seeking a skilled Clinical Research Associate to join our team.
About the Role
The ideal candidate will have a strong understanding of clinical data standards and be able to work effectively with cross-functional teams to deliver high-quality results.
Responsibilities
- Develop and execute testing plans for clinical study setup configurations, including protocol parameters, visit schedules, and form designs.
- Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
- Validate external data acquisition (Lab, ECG, PK/PD) and ensure accurate processing.
- Review edit check specifications; write and execute UAT scripts.
- Conduct QC on metadata listings and peer review of programming checks.
- Support automation tool validation and standardization of test scripts.
- Ensure consistent use of clinical data standards across programs and repositories.
- Work with Clinical Data Management Systems (e.g., Medidata Rave, Oracle InForm) to validate database builds and data flows.
- Ensure compliance with GxP/GcP and internal SOPs.
- Document and share study-related testing deliverables and lessons learned.
- Solid understanding of SDLC, validation methodology, and document management.
Qualifications
- Bachelor's degree in Computer Science or a related field.
- Relevant certifications are a plus.
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