Protocol Specialist - Lead (Remote)

Essential Responsibilities

• Track and monitor incoming study protocols, amendments and related documentation to ensure all study forms are updated accurately and in a timely manner.
• Present draft forms during the Forms Committee Meetings (FCMs).
• Develop, format and maintain study-specific documentation, including Eligibility Checklists, Study Schedules, and other protocol-driven tools.
• Collaborate with site leadership to incorporate required revisions to the form templates.
• Maintain strict document version control by consistently utilizing tracked changes and adhering to established document management standards.
• Review and provide quality oversight of study forms developed by Protocol Specialists to ensure accuracy, consistency, and compliance with protocol requirements.
• Interpret and apply study protocol requirements to support research operations and study conduct.
• Collaborate with Clinical Research Coordinators (CRCs) to ensure protocol requirements are accurately translated into operations documents.
• Attend Site Initiation Visits (SIVs) and other study-related meetings to obtain and incorporate protocol-specific information.
• Serve as an active participant in Forms Committee Meetings by presenting study materials and facilitating protocol review discussions.
• Collaborate 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.
• Utilize other tools such as OnCore and Citeline Parsing to maintain and improve research operations and departmental objectives.

Required Education And Experience

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

Physical & Travel Requirements

• Sitting: Must be able to sit for extended periods of time, approximately 80% of the time.
• Frequent use of computer, keyboard, and mouse.
• Demanding deadlines and time frames
• Constant demand for updating knowledge

Best-in-Class Benefits and Perks

• Comprehensive health coverage: Medical, dental, and vision insurance provided
• Rothvest 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

About The START Center for Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world.