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

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 a 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.

Other key 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.

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.

The important thing for us is you are comfortable working in an environment that is:

• •Fast paced : where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
• •Changing priorities constantly asking you to prioritize and adapt on the spot.
• •Teamwork and people skills are essential for the study to run smoothly.
• •Technology based . We collect our data directly into an electronic environment.

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 .