Description
Job Responsibilities:* Participate in sponsor screen design review meetings.
* Write validation / derivation procedures based on the Edit Check Specification, eCRF specification or data capture instrument and the protocol.
* Conduct quality control of study build and design activities including eCRF specification or annotated data capture instruments, screen design, validation checks and edit check specification.
* Setup test system environments and may coordinate project team members for execution of test scripts.
* May take on responsibility for studies to ensure the databases and validation procedures are ready in a timely manner.
* May create validation documentation including the EDC Testing Plan and EDC Study Test Report.
* May participate in client meetings, study initiation visits, and study update meetings.
* Regularly inform Project Manager and/or client of progress of projects, potential problems, and overall status of the study build and design.
* Participate and support in developing and implementing improved SOPs, validation standards, and work procedures as required. Education:* University/college degree (computer science, life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). Qualifications: * Minimum of 2-3 years of clinical research experience in database maintenance and programming (additional experience may be substituted for education requirements).
* Knowledge of Simple Query Language (SQL) is required.
* Knowledge of EDC or Oracle Clinical database is required.
* Knowledge of data management is required.
* Knowledge of Simple C# language is preferred.
To find out more about Real Staffing please visit www.realstaffing.com