Clinical Research Coordinator/ Madison, WI (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 an Clinical Research Coordinator, 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 Madison, WI.

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.

Many Coordinators are drawn to their profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, you´ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you´ll touch many patient´s lives around the world.

Overall accountability for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff and ensuring that all studies are conducted in accordance with regulatory and protocol requirements, and standard operating procedures whilst maintaining the safety and integrity of the study. The Clinical Research Coordinator is the primary site contact for the Project Manager (PM) communicating any potential issues and assists in taking appropriate action in response to these issues, ensuring that client requirements and timelines are always met or exceeded. Independently undertakes routine studies and more complex studies with guidance. May coach and mentor Operations coordinators and junior staff.

• →University/college degree desirable (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 3 years’ experience in a related field will be considered  
• →Typically, a minimum 3-4 years’ experience in a research environment
• →Knowledge of protocol designs, study objectives and study procedures
• →Knowledge of drug development process, ICH guidelines and GCP
• →Previous customer service experience desirable
• →Previous experience of coordinating people or processes desirable.

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.

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.