Clinical Research Associate

Job Summary
We are seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. Ensuring accurate, timely, and consistent data reaches the clinical teams and other groups.
Roles &

Responsibilities

ResponsibilitiesFacilitate Study Start up activities at Clinical Investigational SiteConduct Feasibility & assess the dataConduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications, site staff adequacy, site facilities, patient pool & share feedback to project teamCollection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissionsIdentify the training needs for the site to perform adequate conduct of trialEnsure supply of clinical trial material to sites before study initiationEnd to End clinical investigational site management:Initiate the study at clinical investigational sitesProvide study protocol and related trainingsPerform review of Informed Consent forms and narrativePerform review of source records, perform SDVReview of CRF data entry, data queries and coordinate with sites to resolveEnsure timely completion and review of site visit reports and addressing action items via follow up letters, tracking of action items till closureIP accountability and reconciliationEnsure adequate initial supply & re-supply of IP per study plan to clinical trial sitesProvide adequate oversight to IP collection, storage, temperature monitoring including review of log, administration to study subjectsIdentification of any temperature excursions and suitability of IP for subject administrationEnsure destruction of expired / used IP on site or return of such IP back to local depot, per study requirement & adequate documentation for same.Review of completion of logs, filing of relevant shipment etc. documentation in site / pharmacy file.Site Contracts and Site Payment CoordinationCoordinate for CDA, Clinical trial agreements review and finalization and amendments, as applicableEnsure that site invoices are being generated as per clinical trial agreementReview and approval of site invoices and submission to payment processing teamCoordinate for the payment release & confirm for site acknowledgementsPerform ongoing reconciliation of payments against site activities including subject visits conduct etc.Liaising with safety lab for timely samples receipt, processing and release of reports & identify, resolve any issues / risks around same.Ensure that the Bio-analytical samples are stored as per storage conditions mentioned in the lab manual including reconciliation and query resolutionLiaising with other vendors and help sites in any query resolutions for vendor related activitiesLiaising with internal project teams including but limited to Data Management for EDC issues, data queries and reconciliations, Safety team for SAE related issues, Medical team for any protocol / eligibility related queries etc.Liaising with Internal & External StakeholdersEnsuring Compliance to Protocol & Applicable study plans, SOPs, GCP and regulatory requirementsEnsure compliance to ProtocolEnsure compliance to study plans, applicable SOPs and related regulatory requirementsEnsure compliance to ICH GCPEnsure compliance to good documentation practices including ALCOA-CIdentification of significant deviations to protocol / plans / procedures, escalation to project lead / clinical ops lead and propose adequate mitigation plans / CAPA, Review of implementation of CAPA / mitigation plans, identify need for training and provide training / re-training in case of any changesSupport audits, inspections / QC visits, as required per study plansTrial Master File Review and Maintenance for Inspection ReadinessEnsure that sites are timely updating the documents in Investigator site fileRetrieval of essential documents from sites for In house filing / Central filesReview of onsite and in house files at defined frequency per monitoring / TMF plan for studyEnsure adequacy of TMF for all time inspection readiness