Study Coordinator II / Madison, WI (On-site)

Responsibilities

• Responsible for practical/administrative activities in support of a clinical research trial.
• Supports and assists the senior study team members such as the Clinical Research Coordinator and Project Manager as appropriate.
• Assists the Clinical Research Coordinator with their responsibilities and acts as their back-up as needed.
• Assists and/or is responsible for the creation of source documents, labels, and study specific instructions.
• Assists and/or is responsible for creation of study schedules.
• Orders supplies/equipment and dietary needs for assigned studies.
• Liaises with CRU contracted services, such as clinical labs and ECG services.
• Coordinates tasks related to participant check in and discharge and may assist with resolution of participant issues.
• Is present in the clinical work areas for critical events or as assigned by a senior team member.
• Completes sample shipment documentation as necessary. May assist with sample shipments as needed.
• Compiles data tables/summaries as requested.
• Aids in the on-time CRF completion and query process as appropriate.
• Aids in the compilation of protocol and SOP deviations.
• Provides logistical feasibility for protocol development.
• Attends all required meetings as appropriate.
• Maintains skills to perform study tasks and assists with study procedures as necessary.
• Maintains accurate records of all work undertaken.
• Maintains an understanding of FDA, GCP and ICH requirements.
• Maintains constant awareness of participant safety and dignity at all times.
• Ensures that client and participant confidentiality is maintained.
• Responds to team queries in a timely manner.
• Takes ownership for the quality and standard of own work.
• Evaluates current SOP’s and authors additions/revisions.
• Trains and instructs less experienced staff.
• Performs other related duties as assigned.

Requirements

• University/college degree (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).
• In lieu of a degree, typically 2 years’ experience in related fields (e.g., pharmaceutical, laboratory, data analysis) will be considered in addition to the experience requirement.
• Basic knowledge of computers and programs (e.g., Microsoft Word, Excel).
• Knowledge of drug development process, ICH Guidelines and GCP.
• Basic Life Support Skills (BLS) or CPR/AED Certified.