Sr. Supervisor / 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 a Sr. 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 and responsible for staff which may consist of RNs, LVN/LPNs, Research Technicians, Clinical Research Coordinators (CRCs) and Operational Coordinators (OCs)

• 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 assignment and coordination of protocols as required.

• Assist with client visits and interactions as appropriate

• 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.

• 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 good communications with both internal and external clients are maintained.

• 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 and training programs.

• Ensures that up to date manuals of SQPs and Policy and Procedures are available to all personnel in his/her work area.

• May perform CRC and QC duties/responsibilities in the absence of team QC or CRC.

• Updates or creates SQPs/P and Ps germane to their area of expertise.

• Schedules all staff as appropriate for study and 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 prob