Operations Coordinator I

Operations Coordinator I

Office based in Madison, WI

Job Overview:

Responsible for practical/administrative activities in support of a clinical research trial. The Operations Coordinator I supports and assists the senior study team members such as the Clinical Research Coordinator and Project Manager as appropriate.

Summary of 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.
• 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.
• 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.
• 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.
• Train and instruct less experienced staff.
• Performs other related duties as assigned.
• And all other duties as needed or assigned.

Qualifications (Minimum 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 year's 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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills:
• Speaking: Yes, English, and applicable local office language.
• Writing/Reading: Yes, English, and applicable local office language.

Experience (Minimum Required):

• 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).
• Knowledge of drug development process, ICH Guidelines and GCP.

Physical Demands/Work Environment:

• Handling of biologically hazardous or radiolabeled material is necessary.
• Must be able to see (distinguish colors) and hear.
• Must have an excellent command of the English language, both oral and written.
• Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a computer keyboard, for up to 6 hours a day.
• Must be able to stand and or/bend for up to 6 hours per day.
• Moving and handling boxes (involves bending and lifting).
• Will require flexibility in working hours according to the demands of the Unit, including off hours and weekend work.
• Vaccination for Hepatitis B as required by local regulations.
• Travel Requirements:
• less than 5.0% of the time for potential cross-site support needs or external training needs.

Learn more about our EEO & Accommodations request here.