Job Title: Clinical Operations Supervisor II
Location: Dallas, TX
Category: Clinical
Job ID: 254595
Job Summary:
The Clinical Operations Supervisor II leads and supervises clinical study staff, ensuring all aspects of clinical studies are conducted to the highest quality according to protocol, SOPs, and ICH/GCP standards. The role includes staff coaching, training, mentoring, and operational management in a fast-paced, team-oriented, early-phase clinical research environment.
This is a full-time, office/clinic-based position.
Key Responsibilities:
1. Leadership & Staff Management:
Directly supervise RNs, LVN/LPNs, and Research Technicians.
Provide leadership, coaching, and mentoring to study staff.
Perform supervisory duties including interviewing, hiring, training, intervention, discipline, and discharge of staff.
Ensure staff are adequately trained, maintaining up-to-date training files in compliance with SOPs and ICH/GCP.
Schedule staff to meet clinic requirements and forecasted workload.
Promote a culture of quality, client satisfaction, and continuous improvement.
2. Clinical Operations & Study Oversight:
Ensure all practical aspects of clinical studies are conducted according to protocol, SOPs, and ICH/GCP standards.
Assist with study planning, set-up, and coordination of relevant protocols.
Ensure safety, welfare, and dignity of research participants are maintained.
Maintain accurate and complete data records, including CRF products that meet client expectations.
Track and evaluate interdepartmental Monthly Key Result Indicators.
Assist with study procedures as necessary.
3. Quality & Compliance:
Ensure all work adheres strictly to protocols, SOPs, and ICH/GCP requirements.
Respond constructively to management and QA, addressing deficiencies with prompt remedial action.
Continuously seek new ideas and best practices to improve operational quality and efficiency.
Update or create SOPs/Policies & Procedures relevant to the area of expertise.
4. Safety & Environment:
Ensure a safe working environment and safe working practices are employed.
Handle biologically hazardous and radiolabeled materials safely.
Requirements:
Education & Certifications:
BS in Science or Medical field, or LPN, LVN, or AD degree.
Six Sigma Green Belt preferred.
Mandatory immunizations and screening as required.
Experience:
Minimum 3–5 years of people management/direct reports experience.
Experience supervising clinical research staff preferred.
Skills & Competencies:
Excellent oral and written command of English.
Ability to stand, bend, and use hands for up to 6 hours per day.
Comfortable working in a fast-paced, technology-based, team-oriented environment.
Ability to prioritize and adapt to changing priorities.
Knowledge of ICH/GCP standards.
Physical Requirements:
Must be able to see (distinguish colors) and hear to meet job requirements.
Overtime and weekend work as required.
Compensation & Benefits:
Eligible for comprehensive benefits if working 20+ hours/week, including:
Medical, Dental, Vision, Life, STD/LTD insurance (multiple carriers)
401(K)
Paid Time Off (PTO)
Employee recognition awards
Multiple Employee Resource Groups (ERGs)
Work Environment:
Fast-paced, technology-driven, team-oriented clinical research environment.
Additional Information:
Learn more about our EEO & Accommodations request.
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