Protocol Specialist (Remote)

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

WORK SCHEDULE

Monday‑Friday 8:00 am – 5:00 pm

ESSENTIAL 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.

REQUIRED EDUCATION AND EXPERIENCE

High school diploma or equivalent. One year of research administrative experience within a health care, pharmaceutical or research organization. Knowledge and training in general office administration skills, including computer applications and filing systems. Familiarity with medical terminology. Strong organizational skills and a sense of timeliness in completing projects. Detail‑oriented and able to understand instructions and work independently.

PHYSICAL & TRAVEL REQUIREMENTS

Approximately 80 % of the time spent sitting. Very fast‑paced and ever‑changing health care environment. Demanding deadlines and time frames. Constant demand for updating knowledge.

BENEFITS

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 options provided. Collaborative, creative environment with opportunities for learning and growth.

MORE ABOUT THE START CENTER FOR CANCER RESEARCH

Deeply rooted in community oncology centers globally, START 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 eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families and physicians around the world. Ready to be part of a team changing the future of cancer treatment? Submit your application online. We are an equal‑opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, disability, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status or any other status protected under federal, state or local law. #J-18808-Ljbffr The START Center for Cancer Research