Job Title

Clinical Research Coordinator II (CRC II) - ContractorLocation: Phoenix, Arizona (On-Site)Employment Type: Full-Time | ContractedCompensation: $27-$36/hour (based on experience and qualifications)About Axsendo Clinical ResearchAxsendo Clinical Research is a community-focused clinical research organization committed to expanding access to high-quality, industry-sponsored clinical trials. We partner with community-based practices to deliver studies on time and on budget-while accelerating time to market and increasing representation in clinical research.Our mission is to extend research access into under-served and historically underrepresented communities, empowering patients with high unmet medical needs to participate in clinical trials that improve health outcomes. Axsendo supports sponsors in diversity planning and the development of effective community engagement strategies.We are building a research model centered on operational excellence, regulatory integrity, and trusted physician-patient relationships.Position OverviewThe Clinical Research Coordinator II (CRC II) is a senior-level research professional responsible for independently managing multiple interventional clinical trials under the direction of the Principal Investigator (PI). The CRC II demonstrates strong operational ownership, regulatory fluency, and the ability to execute complex protocols with minimal oversight.This role requires a dependable self-starter who brings excellence, focus, accountability, and consistent follow-through to daily site operations. The CRC II will serve as a key driver of study timelines, enrollment performance, regulatory readiness, and participant experience.The ideal candidate thrives in a performance-oriented clinical research environment and takes pride in delivering high-quality work with precision and integrity.This position reports to the Director of Clinical Operations.Key ResponsibilitiesRegulatory & ComplianceEnsure compliance with ICH/GCP guidelines and applicable local/state regulationsMaintain and organize essential regulatory documents and study filesTrack study activities to ensure adherence to SOPs, protocols, and institutional policiesPrepare for and participate in sponsor and CRO audits/inspectionsIdentify and appropriately report adverse events (AEs), serious adverse events (SAEs), protocol deviations, and unanticipated problemsStudy Start-Up & OversightSupport feasibility assessments for sponsor-initiated studiesAssist with site start-up activities including regulatory submissions and study activationCoordinate and lead pre-study, site initiation, monitoring, and close-out visitsServe as primary site contact for sponsors and CROsParticipant Coordination & RecruitmentCoordinate participant screening, informed consent, and study visits per protocolSupport recruitment initiatives, including educational and outreach materialsServe as a trusted point of contact for study participantsMonitor enrollment progress and implement recruitment strategies as neededClinical & Data ManagementCollect, process, and manage study specimens (phlebotomy and sample processing preferred)Ensure accurate and timely data entry into EDC and other clinical systemsManage investigational product accountability, storage, and shipmentCoordinate laboratory and diagnostic testing, ensuring timely review and reportingOperations & CommunicationProvide regular updates to the Principal Investigator and site leadershipMaintain study supply inventory and coordinate ordering as necessaryParticipate in Investigator Meetings, trainings, and ongoing professional developmentSupport risk identification, mitigation planning, and operational improvementsQualificationsEducation & CredentialsBachelor's degree in Biology, Nursing, or other healthcare-related field strongly preferredLicensed Registered Nurse (BSN) highly desirableCCRC or CCRP certification preferred (or willingness to obtain within 12 months)Required ExperienceMinimum 2+ years of clinical research experience, including independent coordination of interventional trialsExperience in vaccine, cardiovascular, respiratory, device, or other complex therapeutic areas strongly preferredDemonstrated expertise in ICH-GCP guidelines and regulatory complianceExperience managing moderate- to high-enrolling studies with minimal supervisionProven experience preparing regulatory submissions, maintaining essential documents, and ensuring audit readinessStrong competency in identifying, documenting, and reporting AEs, SAEs, and protocol deviationsClinical skills including phlebotomy, specimen processing, ECGs, vital signs, and participant assessments preferredProfessional AttributesDependable, accountable, and highly organizedSelf-starter with strong initiative and execution disciplineDemonstrates excellence in work quality, attention to detail, and follow-throughStrong time management skills and ability to prioritize competing demandsClear and confident communicator with sponsors, CROs, investigators, and participantsComfortable operating in a fast-paced, growth-focused research environmentBilingual (Spanish-speaking) candidates strongly preferredAdditional RequirementsMust provide a minimum of two professional referencesAbility to lift approximately 20 pounds and stand for extended periodsSome travel in and around the Phoenix area may be required based on study needsEqual Opportunity StatementAxsendo Clinical Research is proud to be an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace free of discrimination and harassment. Employment decisions are based on business needs, qualifications, and performance, without regard to any characteristic protected by law.