Clinical Research Coordinator (Oncology)

SQRL; Walnut Creek (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

15 days PTO

10 company holidays

Health/dental/vision insurance

4% 401(k) employer match

Job summary

SQRL, a fast-growing clinical research site network, is seeking an Oncology CRC to coordinate sponsor-backed trials from start-up through close-out. All work follows SOPs, GCP, IRB, and sponsor protocols, performed on-site in Walnut Creek.

You will lead protocol start-up, recruitment, informed consent, visits, lab processing, billing reconciliation, and audits, ensuring high-quality data and participant safety.

Qualifications

• 2+ years of CRC experience in oncology trials.
• Strong knowledge of GCP, IRB, and regulatory documentation.
• On-site work availability in Walnut Creek (Mon–Fri).

Responsibilities

• Lead site-level start-up activities: regulatory binder, 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, and eligibility requirements.
• Own recruitment strategy for assigned protocols: chart review, referral coordination with treating oncologists, and pre-screening against criteria.
• Conduct the informed consent discussion, ensuring understanding of diagnosis, trial purpose, and prior treatment impact on eligibility.
• Perform and oversee protocol-specified procedures with clinical justification and disease-state knowledge.
• Schedule, conduct, and manage the full cycle of patient visits per protocol and sponsor timeline.
• Coordinate with pharmacy on investigative product accountability: dispensing, storage, and reconciliation.
• Support PI to identify, grade, and report adverse events per protocol timelines and Flourish SOPs.
• Oversee lab processing: kit management, storage, shipping, and chain-of-custody documentation.
• Maintain complete study files and source documentation for sponsor/regulatory review.
• Prepare for and host monitoring visits; resolve data queries with the monitor.
• Enter and reconcile CTMS billing and visit-based charges for protocols against the budget.
• Support sponsor audits and inspections, pulling requested source documents and implementing corrective actions.
• Prepare for and support sponsor site visits, ensuring documentation readiness and timely resolution of findings.

Skills

Oncology CRC experience

Clinical research regulations

Site start-up coordination

Job description

• Comprehensive benefits including 15 days PTO, 10 company holidays, health/dental/vision insurance, and a 4% 401(k) employer match
• Work with cutting edge oncology research trials!

COMPANY

Our client is a fast-growing clinical research site network with more than 30 locations across 10+ states and a national footprint that continues to expand. The organization conducts clinical trials across multiple therapeutic areas and offers significant opportunities for employees to grow as the network adds new sites, capabilities, and leadership opportunities.

POSITION

Our client is hiring an Oncology CRC coordinates sponsor backed, oncology research studies from start-up, conduct, and close-out. All work is performed in accordance with company SOPs, policies and procedures, federal regulations, medical ethics, Good Clinical Practice, ICH guidelines, IRB requirements, and sponsor protocol requirements.

RESPONSIBILITIES

• 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 the mechanism of action, standard of care comparator, and rationale for the eligibility and safety requirements written into the protocol.
• 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.
• 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
• 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 for assigned protocols: dispensing, counting, storage condition monitoring, drug reconciliation at each visit and at study close-out, and destruction documentation, all reconciled against the drug accountability log without error.
• 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.
• Oversee all lab processing for assigned protocols: kit management, processing, storage conditions, shipping, and chain-of-custody documentation, ensuring nothing is missed in a patient population where a lab error is a safety issue, not just a data issue.
• Maintain complete, contemporaneous, accurate source documentation and study files (filing, binder management, logs) that will hold up to sponsor and regulatory review without correction.
• Prepare for and host monitoring visits; resolve data queries directly with the monitor, applying clinical judgment where the answer isn't a simple correction.
• 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.
• Support sponsor audits and regulatory inspections for assigned protocols: pulling requested source documents, answering procedural questions, and implementing corrective actions assigned to them.
• Prepares for and supports sponsor site visits, ensuring documentation readiness and timely resolution of monitoring findings

QUALIFICATIONS

• 2+ years of experience as a CRC working with oncology research trials
• Strong understanding of clinical research regulations, GCP, IRB requirements, study start-up, and regulatory documentation
• Ability to work on site Mon - Fri in Walnut Creek