Clinical Research Coordinator

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 in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, 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. WESEEYOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! We are actively hiring a Clinical Research Coordinator to support our Valkyrie Clinical Trials Denver, Colorado site. LOCATION : Onsite FLSA : Non-Exempt HOURS : Monday to Friday, Day Shift, 40 hours per week COMPENSATION : $27-44 per hour (depending on experience) ESSENTIAL JOB FUNCTIONS: Read,understand,andensurethecompletion ofallprotocolrequiredpatientvisitsandprocedures Clearly and concisely documentpatient assessments,treatments,observations, test resultsand other study related information per federal regulations, protocolrequirementsand GCPGuidelines. Obtainpatientinformedconsent, and reconsent asrequired,accordingtofederalregulations,GCPandIRBrequirementswhile educating patients on studyrequirements, timelines, and visit expectations. AsSenior CRC, lead and mentor otherresearchstaffand serve as anescalation point and SME. Isdiligentinenrolling qualifiedstudyparticipantsintoappropriateprotocolswithinthe sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines. Completeallrequired traininginatimelymanner. Scheduleandconductpatientvisitsaccordingtoprotocol requirementsandtimelines. Maintainwrittensource documentation of patient visits and protocol relatedactivitiesper ALCOA guidelines Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheetsandrespond toqueriesgenerated by thesponsorina timelymanner Maintain confidentialityofallpatient and protocolactivities and informationasappropriateand as boundbyConfidentiality Agreements withValkyrie/Flourish Research,betweenValkyrie/Flourish and sponsors, and betweenValkyrie/Flourish and other entities, as well as HIPAA regulations. Promptlydocument andreportadverseeventstosupervisorand/orPrincipalInvestigator/Sub-Investigatorasdeemednecessary. Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to the supervisor, PrincipalInvestigatorand/or Sub-Investigatorimmediately. Account for clinical trial materials (i.e., CRFs,studydrug, lab supplies, and/or other required items) and ensure availability ofappropriate amountsfor the conduct of the study. Maintain ongoing communication withTeam Lead I; Team Manager/Research Manager;Principal Investigator; Sub-Investigators and other peopleassistingwiththetrial anddocumentingthese communications accordingto protocol requirements andValkyriepolicies. Attend required training courses/conferencesin order tostay abreast of current and changing federal regulations andValkyriepolicies. Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research. AttendInvestigatorMeetings, SIVs,team meetings,and/orothertrainingsasdirected. Performallstudy-relateddutiesinatime-andcost-effectivemannerinadherencewithValkyrie,policies. RepresentValkyrie,Clinical Trialsin a professional and courteous manner (verbal, written and in appearance)wheninteractingwithValkyriestaff,sponsors,IRBs,patients/participants,nursingand medical staff members of various clinics, hospitals, and physician’s offices. Additionaldutiesasassignedbymanagement. PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS: Work is normally performed in a typical interior/office work environment. Travel required but minimal. Exposure to human bodily fluids. Laboratory processing procedures. Participant care. Daily computer use. Occasional night and weekend work schedules. The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds. The ability to drive, and daily availability of an automobile. MINIMUM REQUIREMENTS: Bachelor's degree preferred but not required. Experience: Education:Bachelor'sdegreepreferred;however,isnotrequired.Clinical research certification is a plus Experience:Aminimumof 1-3years’ clinical research experience, with at least 1 year in oncology. Experiencein early phase oncology research preferred. Knowledge and Skills: Exceptionalknowledgeofclinicalresearchmethods. Strongmanagementandleadershipskills. Demonstratedabilitytocollaborateandalignwithoperations. Excellentoralandwrittencommunicationskills. ExcellentcomputerskillstoincludeOffice365products. ExperienceinwritingandreviewingStandardOperatingProcedures. Strongproblemsolving, riskassessmentandimpactanalysisabilities. Demonstratedexperienceinprocessimprovement. Strongnegotiationandconflictmanagementskills. Flexibleandabletomulti-taskandprioritizecompetingdemands. Abilitytothinkindependentlyandinfluencewhenappropriate. Developsand implementskeyinitiativesinthedepartment. Identifiesandimplementsprocessimprovementsforincreasedefficiency. Buildsandfostersrelationshipsacrossteams. Servesaspreceptor,mentorandsubjectmatterexpertindepartment. Demonstratesstrongcriticalthinkinganddecision-makingskills. Continuallydemonstratescorevaluesandisregardedasaleader. Highproficiencyofskillsset. Musthaveindustrycertification,asapplicablebyValkyrie Clinical Trials. Flourish Research offers an excellent comprehensive benefits package to include: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 employmentopportunityemployer. 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 Researchcomplies withthe lawregardingreasonable accommodation for handicapped and disabled employees. #J-18808-Ljbffr