Sr CRA II Home based - assigned to client
Syneos Health
Argentina- ARG
hace 2 días

JOB SUMMARY

The Senior Clinical Research Associate II (SCRA II)will perform monitoring and site management activities for Phase I-IV clinicalresearch projects to assess the progress of clinical projects at assignedinvestigative / physician sites (either on site or remotely) and to ensureclinical projects are conducted, recorded, and reported in accordance with theprotocol, Company and Sponsor standard operating procedures (SOPs), ICH-

GCP,and all applicable local and federal regulatory requirements.Performs all tasks routinely andindependently.Mentors and / or trains, aswell as may assume line management responsibilities for less experiencedemployees.

May assume clinical functional leadership tasks as assigned, actingas Lead CRA for a project.

JOB RESPONSIBILITIES

  • Performs sitequalification, site initiation, interim monitoring, site management andclose-out visits (performed on-site or remotely) ensuring regulatory, ICH-
  • GCP and / orGood Pharmacoepidemiology Practices (GPP) and protocol compliance.Uses judgment and experience to evaluateoverall performance of site and site staff and to provide recommendationsregarding site-

    specific actions; immediately communicates / escalates seriousissues to the project team and develops action plans.Maintains a working knowledge of ICH / GCPGuidelines or other applicable guidance, relevant regulations, and companySOPs / processes.

  • Verifies the process ofobtaining informed consent has been adequately performed and documented foreach subject / patient as required / appropriate.
  • Demonstrates diligence inprotecting the confidentiality of each subject / patient. Assesses factors thatmight affect subject / patient’s safety and clinical data integrity at aninvestigator / physician site such as protocol deviation / violations andpharmacovigilance issues.

  • Per the ClinicalMonitoring / Site Management Plan (CMP / SMP) :
  • oAssesses site processes

    oConducts Source Document Review of appropriate site source documents andmedical records

    oVerifies required clinical data entered in the case report form (CRF) isaccurate and complete via review of site source documents and medical records

    oApplies query resolution techniques remotely and on site, and providesguidance to site staff as necessary, driving query resolution to closure withinagreed timelines

    oUtilizes available hardware and software to support the effectiveconduct of the clinical study data review and capture

    oVerifies site compliance with electronic data capture requirements.

  • May performinvestigational product (IP) inventory, reconciliation and reviews storage andsecurity. Verifies the IP has been dispensed and administered to subjects / patientsaccording to the protocol.
  • Verifies issues or risks associated with blinded orrandomized information related to IP. Applies knowledge of GCP / localregulations and organizational procedures to ensure IP is appropriately(re)labelled, imported and released / returned.

  • Routinely reviews theInvestigator Site File (ISF) for accuracy, timeliness and completeness.Reconciles contents of the ISF with the Trial Master File (TMF).
  • Ensures theinvestigator / physician site is aware of the requirement of archiving essentialdocuments in accordance with local guidelines and regulations.

  • Documentsactivities via confirmation letters, follow-up letters, trip reports,communication logs, and other required project documents as per SOPs and ClinicalMonitoring Plan / Site Management Plan.
  • Supports subject / patient recruitment, retention and awarenessstrategies.Enters data into trackingsystems as required to track all observations, ongoing status and action itemsto resolution.

  • Understands projectscope, budgets, and timelines for own and others’ activities in the clinicalteam; manages site-level activities / communication to ensure projectobjectives, deliverables and timelines are met.
  • Must be able to quickly adapt to changing priorities to achieve goals / targets.

  • May act as primaryliaison with study site personnel, or in collaboration with Central MonitoringAssociate.Ensures all assigned sitesand project-
  • specific site team members are trained and compliant withapplicable requirements.

  • Prepares for andattends Investigator Meetings and / or sponsor face to face meetings.Participates in and may lead global clinicalmonitoring / project staff meetings (inclusive of Sponsor representation, asapplicable) and attends clinical training sessions according to the projectspecific requirements.
  • Providesguidance at the site and project level towards audit readiness standards andsupports preparation for audit and required follow-up actions.
  • Mayprovide direct supervision, training and / or mentorship to more junior levelCRAs. Performs training and sign off visits for junior CRA staff, as assigned.
  • May bementored and assigned lead tasks under supervision of an experienced ClinicalOperations Lead (COL) or operational line manager.
  • This could include participationin business development proposals and / or defense meetings.

  • ForReal World Late Phase (RWLP), the Sr. CRA II will use the business card titleof Sr.Site Management Associate II.Additional responsibilities include :
  • oSitesupport throughout the study lifecycle from site identification throughclose-out

    oKnowledgeof local requirements for real world late phase study designs

    oChartabstraction activities and data collection

    oAsrequired, collaborate and build relationship with Sponsor and other affiliates,medical science liaisons and local country staff

    oThe SMAII may be requested to train junior staff

    oIdentifyand communicate out of scope activities to Lead CRA / Project Manager

    oProactivelysuggest potential sites based on local knowledge of treatment patterns, patientadvocacy and Health Care Provider (HCP) associations.

    oIdentifyoperational efficiencies and process improvements

    oDevelopstudy and country level informed consent forms

    oCollaboratewith RWLP Regulatory team to ensure updated regulatory information is appliedand shared

    oParticipatein bid defense meetings

    oProvideinput into Requests for Proposals (RFPs), scope and budgeting.Develop site management strategy.

    oParticipate in Case Report Form design andedit check development.

    Qualifications

    QUALIFICATION REQUIREMENTS

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
  • Ability to manage required travel of up to 75% on a regular basis
  • Disclaimer :

    Tasks, duties, and responsibilities as listed in this jobdescription are not exhaustive. The Company, at its sole discretion and with noprior notice, may assign other tasks, duties, and job responsibilities.

    Equivalent experience, skills, and / or education will also be considered soqualifications of incumbents may differ from those listed in the JobDescription.

    The Company, at its sole discretion, will determine whatconstitutes as equivalent to the qualifications described above.

    Further,nothing contained herein should be construed to create an employment contract.Occasionally, required skills / experiences for jobs are expressed in briefterms.

    Any language contained herein is intended to fully comply with allobligations imposed by the legislation of each country in which it operates,including the implementation of the EU Equality Directive, in relation to therecruitment and employment of its employees.

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