Clinical Operations Supervisor – Madison, WI (On-Site)
Location: Madison, WI
Category: Clinical
Job ID: 254681
Work Type: Full-time, Office/Clinic-Based
About the Organization
A global leader in Clinical Research with Early Phase Units across the UK and US.
This role supports Phase I trials, including ascending dose, first-in-human, food effect, and drug–drug interaction studies.
Role Overview
The Clinical Operations Supervisor oversees clinical operations staff, ensures protocol compliance, and maintains high-quality standards in Phase I clinical trials.
You will interact directly with healthy volunteers, work with multidisciplinary teams, and contribute to early drug development including safety, tolerability, and PK profiling.
Key Responsibilities
✅ Leadership & Staff Management
Supervise RNs, LPN/LVNs, and Research Technicians.
Lead by example, promote problem-solving, and maintain team productivity.
Conduct interviewing, hiring, training, coaching, disciplining, and staff development.
Ensure adequate staffing levels to meet workload demands.
Oversee scheduling for staff and investigators.
✅ Quality, Compliance & Protocol Adherence
Maintain strict adherence to ICH/GCP, SOPs, and study protocols.
Ensure participant safety, welfare, and dignity at all times.
Implement and support Quality initiatives in assigned areas.
Ensure accurate, complete, and compliant data records.
Respond promptly to QA findings and correct deficiencies.
✅ Training Oversight
Ensure staff have required training and competency documentation.
Maintain complete and current training files in alignment with SOPs and ICH/GCP.
Update or create relevant SOPs and Policies/Procedures.
✅ Operational Responsibilities
Support protocol coordination activities.
Assist in planning study setup.
Ensure high-quality CRF output that meets sponsor expectations.
Comply with all departmental meetings and reporting requirements.
Track & evaluate monthly KPIs across departments.
Support continuous improvement and implement best practices.
Assist with study procedures (e.g., cannulation, telemetry, vitals, ECGs, venipuncture).
✅ Administrative & Budget Responsibilities
Maintain communication with management on operational status.
Contribute to meeting budgeted performance goals.
Required Qualifications
Education & Experience
Option A (Preferred):
BS in science/medical field
3+ years related experience, including 1–2 years research experience
Option B (Alternative):
LPN, LVN, or Associate Degree (AD)
5–7 years related experience, including 1–2 years research experience
Additional experience may substitute for formal education.
Skills & Competencies
Strong knowledge of ICH/GCP standards
Excellent leadership, communication, and interpersonal skills
Ability to work under strict time constraints
Comfort with technology & electronic data capture systems
Excellent English (written & oral)
Ability to multitask and adapt to changing priorities
Work Environment Expectations
Comfortable working in an environment that is:
Fast-paced with zero protocol deviations
Dynamic with constant priority shifts
Highly collaborative requiring strong teamwork
Technology-driven, using electronic data collection systems
Physical Requirements
Stand or remain stationary 6–8 hours/day
Finger/hand movement for keyboard/equipment use up to 6 hours/day
Occasional crouching/stooping; frequent bending/twisting
Lift/carry 15–20 lbs (e.g., luggage, laptop)
Use various in-house/off-the-shelf software
Regular, consistent attendance
Varied hours as required
Special Requirements
Mandatory immunizations and screening
Ability to handle biological and radiolabeled materials
Must be able to distinguish colors and hear effectively
Benefits
Eligible employees (20+ hours/week) receive:
Medical, Dental, Vision insurance
Life, Short-Term & Long-Term Disability
401(k)
Paid Time Off (PTO)
Employee recognition awards
Employee Resource Groups (ERGs)
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