Operations Coordinator I / Daytona Beach, FL (On-Site)

FTCRUDE Fortrea CRU Inc.; Daytona Beach (FL); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

401(k)

PTO

Job summary

Fortrea CRU Inc. is seeking an Operations Coordinator I for our Daytona Beach, FL site. The role focuses on hands-on participation with healthy volunteers, learning protocols, and supporting a fast-paced, team-oriented environment.

You will assist senior team members, coordinate study logistics, and ensure smooth operations across multiple trial types while maintaining regulatory compliance and participant safety.

Qualifications

• University/college degree in life science, pharmacy or related field preferred.
• Certification in allied health profession may substitute for degree.
• 1-2 years of professional work experience in clinical research.
• Basic knowledge of computers and programs (Word, Excel).
• Knowledge of drug development process, ICH Guidelines and GCP.
• BLS or CPR/AED certified.

Responsibilities

• Support practical/administrative activities for a clinical research trial.
• Assist senior study team members such as the Clinical Research Coordinator and Project Manager.
• Set up study logistics to ensure good flow and adequate resources.
• Create source documents, labels, and study-specific instructions.
• Prepare study schedules and orders for supplies/equipment.
• Coordinate with contracted services (labs, ECG).
• Train staff on study procedures and maintain training records.
• Coordinate participant check-in/discharge and resolve issues.
• Maintain accurate records and ensure participant safety and confidentiality.
• Assist with data tables, CRF completion, and protocol deviations.

Skills

Knowledge of FDA/ICH/GC P processes

Computer skills (Word, Excel)

BLS/CPR Certification

Education

Life science degree

Allied health certification

Tools

Microsoft Word

Microsoft Excel

Job description

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US. We are currently seeking an Operations Coordinator I, to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.) This is a full-time, office/clinic-based job in Daytona Beach, FL. Work hours: Monday-Friday, 8am-4pm EST If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

WHAT YOU WILL DO:

• 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.
• 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.

YOU NEED TO BRING…

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 fields (e.g., pharmaceutical, laboratory, data analysis) will be considered in addition to the experience requirement. 1-2 years of professional work experience with at least one year’s experience in clinical research. Basic knowledge of computers and programs (e.g., Microsoft Word, Excel). Knowledge of drug development process, ICH Guidelines and GCP. Basic Life Support Skills (BLS) or CPR/AED Certified.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical
• Dental
• Vision
• Life
• STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO)
• Employee recognition awards
• Multiple ERG’s (employee resource groups)

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Learn more about our EEO & Accommodations request here.

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