Clinical Operations Supervisor Ii / Dallas, Tx (On-Site)

Fortrea

3-5 years

Not Disclosed

Dallas

10 Oct. 4, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧠 Position Title:

Clinical Operations Supervisor II – Dallas, TX (On-Site)

🌍 Location:

Dallas, Texas

🧩 Category:

Clinical

🆔 Job ID:

254595

🏢 Job Type:

Full-time, Office/Clinic-Based

🎯 Job Overview:

As part of one of the largest Clinical Research Organizations (CROs) globally, Fortrea operates four Early Phase Clinical Research Units in the UK and US.

The Clinical Operations Supervisor II is responsible for supervising study staff, ensuring high-quality execution of clinical trials, and maintaining compliance with protocols, SOPs, and ICH/GCP standards. This role involves leadership, coaching, and mentoring of team members while interacting directly with healthy volunteer participants across a variety of therapeutic indications and study types (e.g., ascending dose, first-in-human, food effect, drug-drug interaction).

💼 Key Responsibilities:

🔹 Team Leadership & Supervision

Directly supervise staff, including RNs, LVN/LPNs, and Research Technicians.
Provide training, coaching, and mentoring to ensure team competency and professional growth.
Perform supervisory duties such as interviewing, hiring, training, disciplinary actions, and staff development programs.
Ensure staff adequacy to meet forecasted workload in both quality and quantity.

🔹 Clinical Operations & Quality Oversight

Ensure all clinical study activities are conducted according to protocol, SOPs, and ICH/GCP standards.
Lead by example to encourage team members in problem-solving and quality adherence.
Ensure participant safety, welfare, and dignity are upheld at all times.
Oversee CRF accuracy and data integrity.
Assist with study setup, protocol coordination, and clinic procedures.
Track and evaluate Interdepartmental Monthly Key Result Indicators.
Implement continuous improvement initiatives to drive operational excellence.

🔹 Regulatory & Compliance

Maintain compliance with GCP, ICH, and internal QA standards.
Respond to audits, inspections, and QA inquiries promptly.
Ensure training files and SOP manuals are up-to-date and accessible.

🔹 Administrative & Operational Duties

Manage staff scheduling, including investigators and clinic personnel.
Update or create SOPs/P&P relevant to the area of expertise.
Maintain a safe working environment and oversee proper use of biologically hazardous/radiolabeled materials.
Report to management on operational performance and recommend process improvements.

🎓 Qualifications:

Education:
- BS in Science or Medical Field OR LPN, LVN, or AD degree.
- Six Sigma Green Belt preferred.
- Equivalent experience may substitute for formal education.
Experience:
- 3–5+ years of people management/direct reports experience.
- Experience in Phase I clinical trials and supervisory roles preferred.
Skills & Requirements:
- Strong command of English (oral and written).
- Knowledge of ICH/GCP standards.
- Ability to distinguish colors, hear, and meet physical requirements of the role.
- Ability to use hands for typing or handling tools for up to 6 hours/day.
- Ability to stand/bend for up to 6 hours/day.
- Willingness to work overtime and weekends as required.
- Mandatory immunizations and screenings as required.

⚡ Work Environment & Expectations:

Fast-paced: Adherence to timelines and study protocols is critical.
Dynamic priorities: Ability to adapt quickly and manage changing demands.
Team-oriented: Strong interpersonal skills are essential.
Technology-based: Data is collected and managed through electronic systems.

💰 Compensation & Benefits:

Regular, full-time or part-time employees (20+ hours/week) are eligible for:

🏥 Medical, Dental, Vision, Life, STD/LTD (multiple carriers)
💼 401(k) Retirement Plan
🌴 Paid Time Off (PTO)
🏆 Employee Recognition Awards
🌐 Employee Resource Groups (ERGs)

⚖️ EEO & Accommodations:

Learn more about our Equal Employment Opportunity (EEO) and Accommodations policy [here].

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Clinical Operations Supervisor Ii / Dallas, Tx (On-Site)

Job Description

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