Clinical Research Coordinator, Oncology

Oncology protocols are clinically dense, so full command of the state of the disease, treatment history, and clinical rationale behind each assigned protocol, not only its procedural checklist, is core to this role. Valkyrie's care model is also white glove: participants and their families are never routed around or told no when they hit a logistical obstacle, and the CRC is expected to proactively remove barriers to keep them in care.

Essential Job Functions

Study Start Up

• Lead site-level start-up activities for assigned protocols: regulatory binder build-out, ICF and source document development, supply ordering, and readiness for site initiation visits
• Read and hold full command of each assigned protocol, including mechanism of action, standard of care comparator, and rationale for eligibility and safety requirements

Recruitment, Screening and Consent

• Own recruitment strategy for assigned protocols: chart review, referral coordination with treating oncologists, and pre-screening against inclusion/exclusion criteria
• Conduct the informed consent discussion, ensuring the participant and family understand the diagnosis context, the trial's purpose, and what the treatment history and disease state mean for their specific eligibility

Clinical Skills & Protocol Mastery

• Perform and oversee protocol-specified clinical procedures independently, applying full command of the participant's disease state, prior treatment history, and the clinical rationale behind each assigned procedure
• Recognize when a participant's clinical picture changes in a way that affects protocol eligibility or safety, and act on it rather than waiting to be told

Study Conduct & Investigational Product Management

• Independently schedule, conduct, and manage the full cycle of patient visits per protocol and the sponsor's timeline
• Coordinate with the pharmacy team on investigational product accountability: dispensing, counting, storage condition monitoring, drug reconciliation at each visit and at study close-out, and destruction documentation

Participant Safety & White Glove Care

• Support the PI/Investigator to identify, grade, and report adverse events and serious adverse events per protocol timelines and Flourish SOPs; in oncology this includes correctly distinguishing a treatment-related event from disease progression
• Own the white glove standard for assigned participants: when a participant or family hits a logistical obstacle, the CRC finds a path through it rather than routing them elsewhere or saying no

Laboratory & Specimen Management

• Oversee all lab processing for assigned protocols: kit management, processing, storage conditions, shipping, and chain-of-custody documentation

Good Documentation Practices

• Maintain complete, contemporaneous, accurate source documentation and study files that will hold up to sponsor and regulatory review without correction

Monitoring & Data Query Resolution

• Prepare for and host monitoring visits; resolve data queries directly with the monitor, applying clinical judgment where the answer isn't a simple correction

Site Operations & Financial Administration

• Enter and reconcile CTMS billing and visit-based charges for assigned protocols against the study budget, flagging discrepancies before they become a billing compliance issue

Audits & Inspections

• Support sponsor audits and regulatory inspections for assigned protocols: pulling requested source documents, answering procedural questions, and implementing corrective actions

Study Communication

• Respond to participant and family calls, questions, and concerns promptly and personally
• Maintain the CRC-to-PI communication relationship: bringing the PI clinical questions, safety signals, and protocol deviations that need physician-level judgment
• Acts as the primary site liaison for sponsor and CRO representatives, responding promptly to queries, data clarification requests, and monitoring visit needs
• Communicates enrollment progress, study status, and site performance metrics to sponsors, and escalates protocol deviations or reportable events per required timelines
• Prepares for and supports sponsor site visits, ensuring documentation readiness and timely resolution of monitoring findings

Physical Requirements

• Work is normally performed in a clinical and typical interior/office work environment
• Travel required, including to sponsor meetings, site initiation visits, and training
• Exposure to human bodily fluids and laboratory processing procedures
• Direct participant and patient care
• Daily computer use
• Occasional night and weekend work as needed to support study visits
• Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds
• Ability to drive, with daily availability of an automobile