operations
Posted 19 hours agoOperations Coordinator I / Daytona Beach, FL (On-Site)
at Fortrea
On-site
Responsibilities
- Train and instruct less experienced staff.
- Responsible for logistical set up of study to ensure good study flow and adequate resources are assigned. Assists the Clinical Research Coordinator with their
Requirements
- 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 Study 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.
- Maintains an understanding of FDA, GCP and ICH requirements.
- 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 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.
- Teamwork and people skills are essential for the study to run smoothly. Technology based .
- 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.
- 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.
Experience
- experience requirement. 1-2 years of professional work
Benefits
- 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
Additional details
- 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.
- 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.