Senior Clinical Research Associate I/II

Preferred candidates to be located on the West Coast. 30th October, 2026 Who are we? We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry you'll know that we are experts in our field. Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future. Broad Purpose Avance Clinicalisa ContractResearchOrganisationwhichoffersspecialised servicessupportingdrug developmentforthe pharmaceutical and biotechnologyindustry. The Senior Clinical Research Associate I (SCRA I)performassigned trial related duties and functions ensuring the trial is conductedin accordance withthe protocol; company Standard Operating Procedures (SOPs), ICH GCPguidelinesand other applicable regulatory requirements. Responsibilities include service provision, departmental systems and procedures support and reporting and may include mentoring of junior team members. CoreResponsibilities Conductsiteandinvestigatorfeasibilityactivities. CoordinateHumanResearchEthicsCommitteesubmissionrequirementstocompletion. Developstudy-relateddocumentsorplansunderthesupervisionofthestudyProjectManager. Foramulti-sitestudy,overseeandleadtheoperationsoftheclinicalteamastheLeadCRAincluding development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports. Performallactivities(preparation,execution,andfollow-up)associatedwithonsiteorremotePre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV)andClose-out Visits (COV). Generateandmaintainhighqualityconfirmationletters,sitevisitreports,follow-uplettersandother documentation relatedsitemonitoring and management to ensure compliance with ICH GCP, studyprotocoland regulatory requirements. Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability,meetwithsitepersonnel,andensureproceduresareconductedinaccordancewiththe protocol and ICH GCP. Performprotocolreviewasrequested. RaisedataqueriesintheCaseReportForm(CRF)wherediscrepanciesareidentifiedandworkwithsite staff to ensuretimelyandaccurateresolution. CollectTMFdocumentationfromsiteandensureaccurateandtimelyfilingasperSOPrequirements. Maintaineffectivesitecommunicationtoproactivelymanageon-goingstudyexpectationsandissues. Participateinstudy-specificorvendorauditsconductedbysponsorsorregulatoryagencies,and respond to audit observations, asrequired. EnsureSeriousAdverseEventsarereported(initialandfollow-up)asperprotocolrequirements. Provideguidanceandmentoringtolessexperiencedstaffduringco-monitoringvisitsandfacilitatingaccompanied site visits. Other duties as directed by Line Management or delegatein line withskills,experienceand/orqualifications. 30th October, 2026 Who are we? We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry you'll know that we are experts in our field. Why should you join Avance Clinical? We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future. Broad Purpose Avance Clinicalisa ContractResearchOrganisationwhichoffersspecialised servicessupportingdrug developmentforthe pharmaceutical and biotechnologyindustry. The Senior Clinical Research Associate I (SCRA I)performassigned trial related duties and functions ensuring the trial is conductedin accordance withthe protocol; company Standard Operating Procedures (SOPs), ICH GCPguidelinesand other applicable regulatory requirements. Responsibilities include service provision, departmental systems and procedures support and reporting and may include mentoring of junior team members. CoreResponsibilities Conductsiteandinvestigatorfeasibilityactivities. CoordinateHumanResearchEthicsCommitteesubmissionrequirementstocompletion. Developstudy-relateddocumentsorplansunderthesupervisionofthestudyProjectManager. Foramulti-sitestudy,overseeandleadtheoperationsoftheclinicalteamastheLeadCRAincluding development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports. Performallactivities(preparation,execution,andfollow-up)associatedwithonsiteorremotePre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV)andClose-out Visits (COV). Generateandmaintainhighqualityconfirmationletters,sitevisitreports,follow-uplettersandother documentation relatedsitemonitoring and management to ensure compliance with ICH GCP, studyprotocoland regulatory requirements. Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability,meetwithsitepersonnel,andensureproceduresareconductedinaccordancewiththe protocol and ICH GCP. Performprotocolreviewasrequested. RaisedataqueriesintheCaseReportForm(CRF)wherediscrepanciesareidentifiedandworkwithsite staff to ensuretimelyandaccurateresolution. CollectTMFdocumentationfromsiteandensureaccurateandtimelyfilingasperSOPrequirements. Maintaineffectivesitecommunicationtoproactivelymanageon-goingstudyexpectationsandissues. Participateinstudy-specificorvendorauditsconductedbysponsorsorregulatoryagencies,and respond to audit observations, asrequired. EnsureSeriousAdverseEventsarereported(initialandfollow-up)asperprotocolrequirements. Provideguidanceandmentoringtolessexperiencedstaffduringco-monitoringvisitsandfacilitatingaccompanied site visits. Other duties as directed by Line Management or delegatein line withskills,experienceand/orqualifications. Departmental Responsibilities Foster the on-going commitment tomaintaininga healthy teamcultureandpromotinggoodmorale,by activelyparticipatingin regular Clinical Operations Team meetings. Maintaineffectivecommunicationwithothermembersofthedepartment. Proactivelyidentifyrisksrelatedtodepartmentalserviceprovisionandassistintheirmitigationandresolution. Manageandtrackbusinessrelatedexpensesaspercompanypolicy. IdentifytrainingneedsoftheClinicalOperationsTeamandproviderecommendationsforappropriate trainingactions and programs. ContributetothedevelopmentofdepartmentalSOPsasrequired. ParticipateininternalQualityAssuranceactivitiesasrequired,includingrespondingtointernalauditfindings. Organisational Responsibilities Embrace the core values ofAvance Clinicalandendeavortodisplay those attributes at all timeswith clients and staff alike. Commit toAvance Clinicaltraining programs. Adhere toAvancequality systems. All staffare required totake reasonable care for their own health and safety and that of other personnel who may be affected by their conduct. The accountabilities as specified above may be alteredin accordance withthe changing requirements of the position. Qualifications,Skills,and Experience Bachelor'sleveldegreeinlifesciences,pharmacy,nursing,orequivalentfield. PreviousexperienceasaCRAinaCROorPharmacompanyforatleast3-4years. FormalICHGCPtrainingandaworkingknowledgeofICHGCPGuidelinesandotherapplicable regulatory requirements. Clearunderstandingoftherequirementtoadherestrictlytoclientconfidentiality. Effective written and oral communications skills, including the ability to keep clients, senior managementandotherstakeholdersinformedofprojectupdatesandotherpertinentinformation. Demonstratedabilitytotakeinitiativeinproblemsolvingandinexercising.goodjudgment. AwarenessofPrivacyLegislationasitappliestotheClinicalTrialenvironment. Abilitytoworkunderpressureinamulti-disciplinaryteamenvironment. Willingnesstoworkin,andbesupportiveof,apositiveanddynamicteamculture. Abilitytotravel.Moderatelevelofinterstatetravelmayberequired(upto50%). What we offer Stimulating work Project diversity An intellectual challenge An agile & flexible workplace Opportunity to progress Stability Sense of community A leadership team that are working together on a common goal Flexible work options Great tools / tech to do your job #J-18808-Ljbffr Avance Clinical Pty