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

Role Summary

Clinical Operations Supervisor (Madison, WI) – on-site. Directly interact with healthy volunteer participants in a fast-paced, team-oriented environment. Work with diverse therapeutic indications and study types, within an office/clinic-based setting.

Responsibilities

• Directly supervises staff which may consist of RNs, LVN/LPNs, and Research Technicians.
• Current knowledge of ICH/GCP standards.
• Lead by example and encourage team members to seek solutions.
• Ensure safety, welfare and dignity of research subjects; maintain high quality of service for clients.
• Instill a commitment to quality and meeting client requirements on time, every time.
• Develop and implement Quality within area of responsibility.
• Assist with coordination of relevant protocols and planning of study setup as needed.
• Ensure appropriate training programs and up-to-date training files in accordance with SOPs and ICH/GCP.
• Ensure work is carried out in strict accordance with protocols, SOPs, and ICH/GCP; ensure CRF product meets customer expectations.
• Maintain safe working environment and accurate data records; keep management informed and initiate improvements.
• Manage area to meet budgeted performance; respond to management and QA with prompt remedial action for GCP/ICH deficiencies.
• Perform supervisory duties including interviewing, hiring, training, intervention, discipline, and discharge of operations staff.
• Coach and mentor staff; implement staff development programs; ensure SOPs and policies are available to personnel.
• Schedule investigators for protocol-related tasks; update or create SOPs/POPs as needed; schedule staff for clinic requirements; comply with meeting schedules.
• Assist with study procedures; track and evaluate interdepartmental monthly key performance indicators.
• Apply creative thinking and quality/continuous improvement principles; drive best practices.

Qualifications

• 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 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 job requirements.
• Excellent command of English, oral and written.
• Ability to use hands to operate a computer keyboard for up to 6 hours per day.
• Ability to stand and/or bend for up to 6 hours per day.

Additional Requirements

• Fast-paced environment with strict adherence to study protocols; ability to adapt to changing priorities; strong teamwork and communication skills; data collection in an electronic environment.