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

3-5 years
Not Disclosed
10 Sept. 25, 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

Clinical Operations Supervisor II

Location: Dallas, TX (On-Site)
Category: Clinical
Job ID: 254595
Employment Type: Full-Time

Note: Must have 3–5 years of people management/direct reports experience.


Job Overview

Fortrea, a leading Clinical Research Organization, is seeking a Clinical Operations Supervisor II to oversee Early Phase clinical studies. This role involves direct interaction with healthy volunteer participants, supervising clinical staff, and ensuring studies are conducted efficiently, safely, and in compliance with protocols, SOPs, and ICH/GCP standards. The position offers exposure to a wide variety of therapeutic indications and study types (ascending dose, first-in-human, food effect, drug-drug interactions, etc.).


Key Responsibilities

1. Leadership & Staff Management

  • Directly supervise RNs, LVNs/LPNs, and Research Technicians.

  • Provide leadership, coaching, training, and mentoring to study staff.

  • Perform supervisory duties including interviewing, hiring, training, intervention, discipline, and discharge of operations staff.

  • Ensure staff are adequately trained and maintain up-to-date training files.

  • Instill commitment to quality, client satisfaction, and adherence to protocols.

  • Schedule staff and investigators according to clinic and protocol requirements.

2. Study Operations & Compliance

  • Ensure clinical studies are conducted to the highest quality standards.

  • Maintain CRF and other data records in compliance with SOPs and ICH/GCP.

  • Assist with planning, study set-up, and protocol coordination.

  • Track and evaluate Key Result Indicators (KRIs) and interdepartmental metrics.

  • Ensure a safe working environment and adherence to safe practices.

  • Respond to management and QA on GCP/ICH deficiencies with corrective actions.

3. Quality & Process Improvement

  • Play an active role in quality development and implementation.

  • Update or create SOPs and Policies & Procedures (P&Ps) relevant to the area.

  • Continuously seek out best practices and process improvements.

  • Ensure clinic readiness for audits and inspections.

4. Clinical Support

  • Assist with study procedures as needed.

  • Oversee protocol adherence and participant safety, welfare, and dignity.

  • Support clinical research activities, including handling biologically hazardous and radiolabeled materials.


Qualifications

Required:

  • BS in Science or Medical field, or LPN/LVN/AD degree.

  • 3–5 years of people management experience.

  • Mandatory immunizations and screenings as required.

  • Ability to distinguish colors, hear, and perform manual tasks including computer work (up to 6 hours/day).

  • Ability to stand/bend for up to 6 hours/day.

  • Excellent command of English (oral and written).

  • Comfortable in fast-paced, technology-driven, team-oriented environments.

  • Willingness to work overtime and weekends as required.

Preferred:

  • Six Sigma Green Belt certification.

  • Additional clinical or management experience may substitute for education.


Work Environment

  • Office/clinic-based in Dallas, TX.

  • Fast-paced environment with strict adherence to protocols.

  • Constantly changing priorities requiring flexibility and adaptability.

  • Teamwork and people skills essential for smooth study execution.

  • Data collected directly into electronic systems.


Benefits

  • Comprehensive benefits for employees working ≥20 hours/week:

    • Medical, Dental, Vision, Life, STD/LTD insurance (multiple carriers)

    • 401(K) plan

    • Paid Time Off (PTO)

    • Employee recognition awards

    • Multiple Employee Resource Groups (ERGs)