Clinical Operations Supervisor / Madison, WI (On-site)

Company Name: Fortrea

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 Clinical Operations Supervisor 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 are drawn to this 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.

What You Will Do

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care in clinical research.

Other Key Responsibilities

• Directly supervises staff which may consist of RNs, LVN/LPNs, and Research Technicians.
• Current knowledge of ICH/GCP standards.
• Demonstrate ability to lead by example and to encourage team members to seek solutions.
• Ensure that the safety, welfare and dignity of research subjects are not compromised.
• Ensure the quality of service provided by team members meets the requirements of both internal and external clients.
• Instill in all team members responsible to him/her the Company’s commitment to quality and meeting the client’s requirement without error, on time, every time.
• Play an active role in the development and implementation of Quality within his/her area of responsibility.
• Assist with the coordination of relevant protocols.
• Ensure that appropriate training programs are in place so that all personnel under his/her supervision are adequately and properly trained for their job requirements.
• Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
• Ensure all work in his/her area is carried out in strict accordance with relevant protocols, SOPs, and in compliance with ICH/GCP.
• Ensures that the CRF product meets the customer expectations.
• Assist with planning of study set up, as needed.
• Ensure that the staff under his/her supervision area at all times adequate in quality and quantity to meet the agreed forecasted workload. Recommend changes if necessary and justify them in accordance with company policy.
• Ensure that a safe working environment is maintained and that safe working practices are employed.
• Ensure that full and accurate data records are maintained.
• Keep management up to date on all aspects of his/her job and initiate improvements.
• Manage his/her area so as to meet the budgeted standard of performance.
• Respond constructively to management and QA ensuring that any GCP/ICH deficiencies are followed up with prompt remedial action.
• Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharge of operations staff.
• Coaches and mentors staff. Initiates, plans, and implements appropriate staff development programs.
• Ensures that up to date manuals of SOPs and Policy and Procedures are available to all personnel in his/her work area.
• Schedules investigators for protocol-related tasks.
• Updates or creates SOPs/P&Ps germane to their area of expertise.
• Schedules staff as appropriate for clinic requirements.
• Complies with departmental meeting schedules.
• Assists, as necessary, with study procedures.
• Tracks and evaluates Interdepartmental Monthly Key Result Indicators.
• Works on a wide range of opportunities and problems where use of creative thinking and the application of related quality and continuous improvement theories and principles is required.
• Continuously seeks out new and better ideas, driving best practices.
• BS in science or medical field or LPN, LVN or AD degree.
• 3 years related experience including 1-2 years of research experience with a BS degree.
• Perform study related activities such as cannulation, telemetry, holters, vital signs, ECGs, venipuncture.
• Undertake any other duties as required.

YOU NEED TO BRING…

• 5-7 years of related experience including 1-2 years of research experience with a LPN, LVN or AD degree.
• Additional experience may be substituted for education.
• Mandatory immunizations and screening as required.
• Handling of biologically hazardous and radiolabeled material is necessary.
• Must be able to see (distinguish colors) and hear to meet, if necessary, the job requirements.
• Must have 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 per day.
• Must be able to stand and/or bend for up to 6 hours per day.

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?

Benefits

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 ERGs (employee resource groups)

Learn more about our EEO & Accommodations request here.