Operations Coordinator I

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. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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 II 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.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.