Clinical Outcome Assessment Consultant

Real Staffing Group; Princeton (NJ); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Health savings accounts

Retirement plans

Life and disability insurance

Paid leave where required by law

Job summary

Real Staffing Group is seeking a Clinical Outcome Assessment and Patient Advocacy Consultant for a 12 month contract with a fully remote arrangement. The role leads COA strategy across clinical trials, while overseeing vendor relationships and regulatory compliance, ensuring timely, quality deliverables.

Ideal candidates have 5+ years in COA/eCOA with experience in sponsors, CROs, or eCOA vendors, and familiarity with regulatory requirements; immunology, nephrology, mental health, or neurology

Qualifications

• 5+ years of COA/eCOA experience in clinical trials.
• Experience working with sponsors, CROs or eCOA vendors.
• Knowledge of regulatory requirements for COA/eCOA programs.
• Ability to manage COA Operations and PED projects.

Responsibilities

• Lead global COA strategy execution for clinical trials, including licensing and translation.
• Manage COA Operations and PED projects, ensuring timelines, quality, and regulatory compliance.
• Support evidence generation through qualitative and quantitative research for endpoint development and tool validation.

Skills

COA/eCOA experience

Project management

Vendor management

Regulatory knowledge

Stakeholder communication

Cross-functional collaboration

Tools

eCOA platforms

Job description

• We are currently seeking a Clinical Outcome Assessment and Patient Advocacy Consulant for a Pharmaceutical company. This is a 12 month contract, fully remote opportunity.
• • Leads and supports global COA strategy execution for clinical trials, including licensing, translation, linguistic validation, eCOA implementation, user acceptance testing, data surveillance, and vendor management.
  • Manages COA Operations and PED projects, ensuring timelines, quality deliverables, regulatory compliance, stakeholder communication, and cross-functional collaboration across clinical development teams.
  • Contributes to COA evidence generation through qualitative and quantitative research, supporting endpoint development, tool validation, psychometric analyses, and patient-focused drug development activities.
  • Requires 5+ years of clinical trial COA/eCOA experience, strong project and vendor management skills, knowledge of regulatory requirements, and experience working with sponsors, CROs, or eCOA vendors. Therapeutic area experience in immunology, nephrology, mental health, or neurology is preferred.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.