Operations Coordinator I

$45,760 - $56,160/Yr

Fortrea Inc. - Madison, WI

posted 2 months ago

Part-time,Full-time - Entry Level
Madison, WI
10,001+ employees
Professional, Scientific, and Technical Services

About the position

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. The Operations Coordinator I position is a full-time role based on-site in Madison, WI, responsible for practical and administrative activities in support of clinical research trials. This role supports and assists senior study team members, such as the Clinical Research Coordinator and Project Manager, ensuring that all logistical aspects of the study are well-coordinated and that resources are adequately assigned. The Operations Coordinator I will be responsible for the logistical setup of studies to ensure smooth study flow. This includes assisting the Clinical Research Coordinator with their responsibilities and acting as their backup when necessary. The coordinator will also assist in the creation of source documents, labels, and study-specific instructions, as well as study schedules. Ordering supplies and equipment, liaising with contracted services, and assisting with staff training on study-specific procedures are also key responsibilities. The role requires the coordinator to be present in clinical work areas for critical events and to maintain accurate records of all work undertaken, ensuring compliance with FDA, GCP, and ICH requirements. The Operations Coordinator I must maintain constant awareness of participant safety and confidentiality, responding to team queries in a timely manner and taking ownership of the quality of their work.

Responsibilities

  • Responsible for logistical setup of study to ensure good study flow and adequate resources are assigned.
  • Assists the Clinical Research Coordinator with their responsibilities and acts as their backup as needed.
  • Assists and/or is responsible for the creation of source documents, labels, and study-specific instructions.
  • Assists and/or is responsible for the 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.
  • 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 SOPs 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 a 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).
  • Knowledge of drug development process, ICH Guidelines, and GCP.

Nice-to-haves

  • Experience in clinical trials
  • Familiarity with FDA regulations
  • Strong computer skills

Benefits

  • Employee stock purchase plan
  • Disability insurance
  • Health insurance
  • Dental insurance
  • 401(k)
  • Paid time off
  • Vision insurance
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