Clinical Trial Associate

The Clinical Trial Associate serves as the primary point of contact for administrative support to the site and clinical trial team. The Clinical Trial Associate is also responsible for coordinating the day to day clinical study activities and maintaining the logistical aspects of clinical trials in compliance with protocol, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), local regulations, applicable Standard Operating Procedures (SOPs) and project-specific requirements.
TheClinicalTrialAssociatewillbeinvolvedinmostactivitiesinpreparationforthesetup, conduct, and completion of a clinical trial. This includes, but is not limited to:
Primary TrialMasterFile Duties
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Assumeprimaryresponsibilityforthesetup,development,maintenance,and correspondence of the Trial Master File (TMF) for studies assigned
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Setupandmaintainelectronic filingsystems/setupof theInvestigatorSiteFile (ISF)
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TrackEthics/Regulatorysubmissionsand approvalsfor studies
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Preparedistribute,track,and file essentialclinicaltrial documentation
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Coordinatearchiving ofstudy documentation
CRAand Study Team Support
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AssisttheClinicalResearchAssociates(CRAs)withaccuratelyupdatingandmaintaining clinical systems that track site compliance and performance within project timelines
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ServeasthepointofcontactforCRAassistancewithTMForstudyrelatedmaterial support
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Arrangeandparticipateintheorganizationofinvestigatormeetingsandstudyteam meetings including taking and distributing minutes and tracking of the final document
StudyManagement Support
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AssisttheClinicalTrialManagerinthe siteselection process
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Assist in initial composition of Operations Manual, Pharmacy Binder, and InvestigatorSite File (ISF) Binder, etc.
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Manageandmaintainstudydocumentsandtrialsuppliese.g.;Patient InformationSheets, Patient Diaries, Lab Kits and Medical equipment for sites
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Ensurethatanyclinicaltrialdatabases/trackingtoolsaresetupandmaintained throughout the trial
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Createandmaintainstudycontact listsforteam/sites/3rdparties
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Reviewstudy mailbox andfile emails inappropriate mailbox folders
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Assistinpreparationanddistributionofstudynewsletters/studycorrespondencetoall participating sites on an ongoing basis
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Setupoffinancesystemsaccurately,process invoices andtrack paymentsforthetrialfor investigator and vendor payments
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Assist with collating, tracking and shipping case report forms (CRFs) and data queries to Data Management
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Generalstudyfiling
Otherpossibletasksmayinclude:
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Assist withdesigning ofstudy logs,source document template, etc.
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Arrangetranslationofadvertisementmaterialand patient documents
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Assist CRAsonmonitoring visits
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Reorderclinicaldrugsuppliesforsites
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Otherduties as assigned
#LI-CB1
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Bachelor’sdegree(orequivalent)inscientific discipline
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1 year of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination ofeducation, training and experience). Prior experience in clinical research is preferred.
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WorkingknowledgeofICH-GCP guidelinesandFDA regulations
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Strongverbalandwrittencommunicationskills
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Abilityto workeffectively both independentlyand ina teamenvironment
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Strongorganizationaland planningskills
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Excellentinterpersonalandprofessionalskills
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Excellenttimemanagementskillswiththeabilitytoprioritizeresponsibilitiesand multitask
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Strongadministrative skills
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Excellentdocumentationandfilemanagementskills
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Selfmotivated anddetail oriented
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ProficientinMicrosoftOfficeandable tolearn appropriatesoftware