Clinical Research Coordinator, Oncology

Flourish Research; Walnut Creek (CA); Sur place; USD 51 000 - 66 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) with employer match

Tuition reimbursement

Parental leave

Employee referral program

Life insurance

Disability insurance

Generous PTO and holidays

Résumé du poste

Flourish Research is seeking a Clinical Research Coordinator - Oncology at Valkyrie Clinical Trials in Walnut Creek, CA. The CRC will support start-up, recruitment, data management, and study conduct for complex oncology protocols.

The role emphasizes white-glove participant care, protocol mastery, and tight regulatory compliance within a team-driven environment.

Qualifications

• Bachelor's degree in life science, nursing, or related field preferred; equivalent clinical research experience considered.
• 2-3 years of clinical research experience, including RA or oncology experience.
• Knowledge of GCP/ICH/IRB requirements.
• Strong organizational and communication skills; ability to manage multiple protocols.

Responsabilités

• Lead start-up activities for assigned protocols and regulatory binder development.
• Coordinate recruitment strategies, pre-screening, and informed consent discussions.
• Perform protocol-specified procedures and monitor safety in oncology trials.
• Schedule and manage visits, data queries, and sponsor communications.
• Maintain source docs, study files, and regulatory compliance.

Connaissances

GCP/ICH/IRB knowledge

Protocol mastery

Organization

Communication

CTMS

EDC

Office 365

Formation

Bachelor's degree in life science or related field

Outils

CTMS

EDC

Office 365

Description du poste

Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California and Colorado.

Flourish Research is one of the industry's most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

We are actively hiring a Clinical Research Coordinator - Oncology, to support our Valkyrie Clinical Trials Walnut Creek, CA site.

LOCATION

Onsite, Walnut Creek, CA

FLSA

Non-Exempt

HOURS

Monday to Friday, Day Shift, 40 hours per week

COMPENSATION

$37-48 per hour (depending on experience)

The Clinical Research Coordinator (CRC) coordinates the activities, duties, and procedures required for the start-up, conduct, and close-out of oncology clinical trial protocols at Valkyrie Clinical Trials. The role is responsible for obtaining clean, objective, and accurate data within sponsor timelines while protecting participant safety and maintaining inspection-ready documentation.

Two things distinguish this role beyond standard clinical coordination. 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: a missed detail in this patient population is a safety issue, not just a data issue. 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.

This is the individual contributor level of the Clinical Research Coordinator job family. The band spans coordinators who are new to the role and working toward independent practice through experienced coordinators managing complex oncology protocols independently. Placement and progression within the band are determined by the Flourish Research Oncology CRC Competency Assessment.

All work is performed in accordance with Flourish Research SOPs, policies and procedures, federal regulations, medical ethics, Good Clinical Practice, ICH guidelines, IRB requirements, sponsor protocol requirements, and the Flourish Research Core Values, Mission Statement, and Employee Manual.

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, not just the visit checklist. This includes the mechanism of action, standard of care comparator, and rationale for the eligibility and safety requirements written into the protocol

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, not just the steps
• Recognize when a participant's clinical picture (labs, symptoms, treatment response) 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 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

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 their assigned participants: when a participant or family hits a logistical obstacle (transportation, insurance, scheduling conflict, financial concern) 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, ensuring nothing is missed in a patient population where a lab error is a safety issue, not just a data issue

GOOD DOCUMENTATION PRACTICES

• Maintain complete, contemporaneous, accurate source documentation and study files (filing, binder management, logs) 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 assigned to them

STUDY COMMUNICATION

• Respond to participant and family calls, questions, and concerns promptly and personally; this is the frontline of the white glove relationship and is treated as a priority, not an interruption
• Maintain the CRC-to-PI communication relationship: bringing the PI clinical questions, safety signals, and protocol deviations that need physician-level judgment, and closing the loop back to the participant
• 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
• Additional duties as assigned by management

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

Requirements

MINIMUM REQUIREMENTS

Education: Bachelor's degree in a life science, nursing, or related field preferred; equivalent clinical research experience considered in lieu of degree.

Experience: 2-3 years of clinical research experience, including experience as an RA, or equivalent oncology clinical experience (nursing, oncology clinic, infusion center).

Knowledge and Skills

• Working knowledge of GCP, ICH guidelines, and IRB requirements
• Ability to read and apply a protocol's clinical rationale, not just its procedural checklist
• Strong organizational skills; able to manage multiple protocols and visit schedules concurrently
• Excellent oral and written communication skills, including with participants under emotional or medical stress
• Proficiency with CTMS, EDC systems, and Office 365

Benefits

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.