Clinical Research Coordinator II - Oncology

Clinical Research Coordinator II - OncologyCompany: Lumi ResearchLocation: Greater Dallas Fort WorthEmployment Type: Full-TimeSchedule: Monday – Friday, 8:00 AM – 5:00 PMSalary Range: based on experienceWill travel to satellite sites depending on patient schedules: • Garland • Bedford• Flower Mound • BenbrookSummaryAt Lumi Research, we strive to provide urgent and comprehensive support to community-based oncologists as they deliver cutting-edge treatments to underserved patient populations.The primary purpose of the Clinical Research Coordinator II (CRC II) is to facilitate patient enrollment and support the execution of clinical research activities, including regulatory record keeping, patient consenting and registration, and data and specimen collection for assigned clinical trials.The CRC II will assist with or independently perform patient consenting, patient registration, data collection, and data entry while preparing regulatory documentation for monitoring visits as needed. This role plays a critical part in ensuring the successful onboarding and management of clinical trial participants for protocols conducted by Lumi Research and its clinician partners.Employment StatusFull-time (40 hours per week; not eligible for overtime)Skills Required for Ideal CandidateAbility to apply prior knowledge and skills to complete clinical trial tasks effectivelyStrong critical thinking and problem-solving skills to resolve logistical challengesExcellent professional communication skills (verbal and written) when interacting with clinicians, sponsors, and patientsStrong organizational skills with the ability to follow up on pending itemsAbility to multitask and prioritize responsibilitiesProficiency with Microsoft Office tools and Microsoft Teams for communication and documentationPreferred Skills (Not Required)Ability to perform phlebotomy on clinical trial patients according to protocol collection requirementsPhlebotomy certification preferredRoles and Responsibilities-Regulatory and Administrative Coordinate and attend study initiation visits and planning meetings as part of the research teamMaintain current versions of study protocols and required documentation, including patient treatment consentsCollect and document protocol source information including:Adverse events (serious and non-serious)Completion of adverse event reportingDevelopment of source documentation for assigned protocols with guidance from a Senior CRCAssist with annual protocol review processes, including toxicity report preparation when requiredMaintain delegation of authority logs and training logsMaintain screening and consent logs, including off-study dates and reasons for screen failuresMaintain organized regulatory SharePoint folders across protocolsDevelop working knowledge of Electronic Data Capture (EDC) systems and patient registration systems-Study Coordination Coordinate, monitor, and follow all patient activities while enrolled in clinical trialsUtilize screening checklists to support efficient patient onboardingAssist with maintaining institutional and facility contact lists to resolve logistical challengesConduct the informed consent process under investigator supervision, including:Treatment consentsTissue/specimen collection consentsHealthy participant consentsEducate patients on trial requirements, procedures, and treatment schedulesMaintain knowledge of protocol-specific proceduresCoordinate research-related patient visits including:Screening visitsTissue collection logisticsTreatment visits (imaging, laboratory testing, physician exams, etc.)Create and maintain source documentation as required by protocolEnsure accurate and timely data entry in Electronic Data Capture (EDC) systemsRespond to monitor queries related to data collectionTrack and document protocol deviationsAdminister patient questionnaires when required by protocolMaintain patient tracking tools including:Treatment cyclesLab and specimen collectionData collection and entry statusSupport Principal Investigator (PI) oversight by maintaining accurate patient tracking and providing status updates during sponsor or investigator meetings-Specimen Collection Coordinate and perform specimen collection according to protocol requirements, including:BloodUrineSalivaBuccal swabsOther specimens as requiredPackage and ship specimens in accordance with protocol and laboratory guidelinesRequired EducationBachelor’s degree (degree verification required)Required ExperienceMinimum three (3) years of experience in one or more of the following:Oncology clinical setting (clinic or research laboratory)Clinical trial research experience including:Data entryPatient consentingRegulatory coordinationBench research experienceClinical roles such as:Medical AssistantLaboratory TechnicianSimilar patient-facing clinical rolesEquivalent experience may substitute for the required degree on a case-by-case basis.Candidates must:Provide at least one professional reference from a current or former supervisor or colleagueBe eligible to work in the United StatesPreferred ExperiencePrior experience serving as a Clinical Research Coordinator managing oncology trials (2+ years preferred)Benefits OverviewTwo weeks (80 hours) PTO annually, with accrualMonthly medical benefits stipendClinical research certification support, including assistance maintaining continuing education hours