What are the responsibilities and job description for the Operations Coordinator I position at Fortrea?
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
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
Learn more about our EEO & Accommodations request here.
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.
- 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.
- 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.
- 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.
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
Learn more about our EEO & Accommodations request here.
