Clinical Outcome Assessment Consultant

Real; Princeton (NJ); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Health savings accounts

Retirement savings plans

Life and disability insurance

Paid leave

Job summary

Specialist Staffing Group is seeking a Clinical Outcome Assessment and Patient Advocacy Consultant for a 12-month contract, fully remote. You will lead global COA strategy execution across clinical trials, including coordinating licensing, validation, and vendor management.

The role requires 5+ years in COA/eCOA with strong project management and regulatory knowledge. Immunology, nephrology, mental health, or neurology experience is preferred, with flexible benefits available to eligible

Qualifications

• 5+ years of COA/eCOA experience in clinical trials.
• Experience with sponsors, CROs, or eCOA vendors.
• Experience navigating regulatory requirements.

Responsibilities

• Lead global COA strategy execution for clinical trials.
• Oversee COA Operations and PED projects with timelines and quality.
• Support evidence generation through qualitative and quantitative research.

Skills

COA/eCOA

Project management

Vendor management

Regulatory requirements

Cross-functional collaboration

Clinical trials

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.