Senior Clinical Research Associate I/II

Avance Clinical Pty; United States; À distance; USD 75 000 - 110 000; Plein temps

Avantages offerts par ce poste

Stimulating work

Project diversity

An intellectual challenge

Agile & flexible workplace

Opportunity to progress

Stability

Sense of community

Leadership collaboration

Flexible work options

Great tools / tech to do your job

Résumé du poste

Avance Clinical is seeking a Senior Clinical Research Associate I to support multi-site trials in the United States. The role focuses on site feasibility, monitoring, and regulatory compliance in line with ICH GCP guidelines.

You will collaborate with sponsors, sites, and cross‑functional teams to ensure study integrity and timely delivery. Ideal candidates hold a Bachelor's degree in life sciences or related field, 3–4 years CRA experience, and strong communication and problem‑solving skills.

Qualifications

• Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field.
• Previous experience as CRA in a CRO or Pharma company for at least 3–4 years.
• Formal ICH GCP training and working knowledge of ICH GCP guidelines.
• Clear understanding of client confidentiality requirements.
• Excellent written and oral communication skills.

Responsabilités

• Conduct site and investigator feasibility activities.
• Coordinate Human Research Ethics Committee submissions.
• Develop study documents under supervision of the study Project Manager.
• Lead multi-site study operations as Lead CRA including development of Clinical Monitoring Plan.
• Manage all activities for PSV, SIV, DWV, IMV and COV.
• Ensure documentation and regulatory compliance per protocol/ICH GCP.
• Provide mentoring to less experienced staff during monitoring visits.

Connaissances

Excellent communication skills

Team collaboration

Problem solving

Attention to detail

Initiative

Formation

Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field

Description du poste

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