Operations Coordinator

Duties and Responsibilities:

• Responsible for logistical set up of study to ensure good study flow and adequate resources are assigned.
• 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
• Assists and/or is responsible for staff training of study specific procedures.
• Coordinates tasks related to participant check in and discharge and may assist with resolution of participant issues.
• Completes sample shipment documentation as necessary.
• Compiles data tables/summaries as requested.
• Assists with on-time CRF completion and query process as appropriate.
• Assists with the compilation of protocol and SOP deviations.
• Provide logistical feasibility for protocol development.
• 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.
• Evaluates current SOP's and authors additions/revisions.
• Train and instruct less experienced staff.

Qualifications:

Required: 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 field (e.g. pharmaceutical, laboratory, data analysis) will be considered in addition to the experience requirement.
Basic Life Support Skills (BLS) or CPR/AED Certified
Typically 1-2 years of professional work experience with at least one year experience in clinical research.
Basic knowledge of computer and programs (e.g. Microsoft Word, Excel).

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