Protocol Specialist (Remote)

About the role

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START Center for Cancer Research is seeking a Protocol Specialist (Remote).

Responsibilities

• Review, track and maintain study protocols, amendments, clarification letters, and related study documentation throughout the study lifecycle.
• Interpret and apply study protocol requirements to support research operations and study conduct.
• Develop, format and maintain study-specific documentation, including Eligibility Checklists, Study Schedules, and other protocol-driven tools.
• Collaborate with Clinical Research Coordinators (CRCs) to ensure protocol requirements are accurately translated into operations documents.
• Validate eligibility criteria, visit schedules, assessments and study procedures against approved protocols and amendments.
• Attend Site Initiation Visits (SIVs) and other study-related meetings to obtain and incorporate protocol-specific information.
• Attend Forms Committee Meetings and update forms in collaboration with Investigational Drug Services (IDS), Pharmacokinetics (PK), and other interdisciplinary teams to ensure study documentation reflects protocol requirements accurately.
• Utilize billing grids and study budgets to incorporate billing designations into study schedules and research documentation.
• Enter and maintain study acuity and protocol-related information within OnCore and other applicable clinical trial management systems.
• Ensure accurate document version control through the consistent use of tracked changes, document management standards, and established quality control processes.

Requirements

• High School diploma or equivalent.
• One year of research administrative experience within a healthcare, pharmaceutical, or research organization.
• Knowledge and training in general office administration skills, including computer applications, filing systems, etc.
• Familiarity with medical terminology.
• Strong organizational skills and a sense of timeliness in completing projects.
• Must be detail-oriented and able to understand instructions and work independently.

Qualifications

Approximately 80% of time is spent sitting. Very fast-paced and ever-changing healthcare environment. Demand for updating knowledge. Comprehensive health coverage: Medical, dental, and vision insurance provided. Robust retirement planning: 401(k) plan available with employer matching. Financial security: Life and disability insurance for added protection. Flexible financial options: Health savings and flexible spending accounts offered. Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided.

Benefits and Perks

We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and vision insurance provided.
• Robust retirement planning: 401(k) plan available with employer matching.
• Financial security: Life and disability insurance for added protection.
• Flexible financial options: Health savings and flexible spending accounts offered.
• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided.

Pay

The Hourly range for this role is $23.00/hour - $26.00/hour. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience.

Schedule

Work Schedule Monday-Friday 8:00am-5:00pm