Protocol Specialist

About the Organization

The START Center for Cancer Research is a leading global network focused entirely on early-stage oncology clinical research. Its sites have helped bring more than 45 therapies to FDA or EMA approval, and the network has supported over a thousand early-phase trials across its clinical trial sites.

Role Overview

The remote Protocol Specialist supports clinical trial execution by creating, maintaining, and quality-checking protocol-based research documents. The role ensures that study documentation stays aligned with approved protocols so trial operations can run accurately and efficiently.

Key Duties

• Monitor, update, and organize study protocols, amendments, clarification letters, and other trial documents throughout the full study lifecycle.
• Analyze protocol requirements and apply them to day-to-day research operations and trial conduct.
• Build, format, and maintain study tools such as eligibility checklists, study schedules, and other protocol-specific documents.
• Work closely with Clinical Research Coordinators to make sure operational documents accurately reflect protocol expectations.
• Check eligibility rules, visit timelines, assessments, and procedures against approved protocols and amendments.
• Participate in Site Initiation Visits and other study meetings to gather and incorporate protocol details.
• Join Forms Committee meetings and coordinate updates with Investigational Drug Services, Pharmacokinetics, and other partner teams so forms and documentation stay accurate.
• Use billing grids and study budgets to add billing designations into study schedules and research materials.
• Maintain study acuity and protocol information in OnCore and other clinical trial management systems.
• Protect document accuracy through version control, tracked changes, document standards, and quality review practices.

Work Schedule

This is a remote position with a Monday through Friday schedule, from 8:00 AM to 5:00 PM.

Required Background

Candidates should have a high school diploma or equivalent, along with at least one year of research administrative experience in a healthcare, pharmaceutical, or research setting. Familiarity with medical terminology is important, as are general office administration skills such as computer use and filing systems.

Role Expectations

The position requires strong organization, good time management, the ability to follow instructions carefully, attention to detail, and the capacity to work independently in a fast-moving environment with demanding deadlines. About 80% of the workday is spent sitting.

Benefits and Perks

• Medical, dental, and vision coverage
• 401(k) retirement plan with employer match
• Life and disability insurance
• Health savings accounts and flexible spending accounts
• Paid time off
• Flexible scheduling
• Remote work option
• A collaborative workplace designed to support learning, growth, and contribution to team decisions and culture

About START

START operates as a community oncology and early-phase research network dedicated to advancing novel anti-cancer treatments. Its mission is to help move promising therapies from trials to treatment and provide hope to patients, families, and physicians worldwide.

Equal Opportunity Statement

The organization is an equal opportunity employer and welcomes applicants from all backgrounds. Employment decisions are made without regard to race, color, religion, marital status, age, national origin, ancestry, disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other legally protected status.