CRA II
Syneos Health
Turkey
son 8 saat

JOB SUMMARY

The Clinical ResearchAssociate II (CRA II) will perform monitoring and site management activitiesfor our Pharmaceutical clients for Phase I-

IV clinical research projects to assess the progress of clinicalprojects at assigned investigative / physician sites (either on site or remotely)and to ensure clinical projects are conducted, recorded, and reported inaccordance with the protocol, Company and Sponsor standard operating procedures(SOPs), ICH-

GCP and / or all applicable local and federal regulatoryrequirements.Performs all tasksroutinely and independently, seeking guidance as needed.

JOB RESPONSIBILITIES

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

    specific actions; immediately communicates / escalates serious issues to theproject team and develops action plans.Maintainsa working knowledge of ICH / GCP Guidelines or other applicable guidance,relevant regulations, and company SOPs / 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

    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 assigned actionitems to resolution.

  • For assignedactivities, understands project scope, budgets, and timelines; managessite-level activities / communication to ensure project objectives,deliverables and timelines are met.
  • Mustbe 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 global clinical monitoring / projectstaff meetings (inclusive of Sponsor representation, as applicable) and attendsclinical training sessions according to the project specific requirements.
  • Provides guidance atthe site and project level towards audit readiness standards and supportspreparation for audit and required follow-up actions.
  • Maintainsa working knowledge of ICH / GCP Guidelines or other applicable guidance,relevant regulations, and company SOPs / processes;
  • completes assigned trainingas required.

    Qualifications

    QUALIFICATION REQUIREMENTS

  • Bachelor’sdegree or RN in a related field or equivalent combination of education,training and experience
  • Knowledgeof Good Clinical Practice / ICH Guidelines and other applicable regulatoryrequirements
  • Mustdemonstrate good computer skills and be able to embrace new technologies
  • Excellentcommunication, presentation and interpersonal skills
  • Abilityto 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.

    Why Syneos Health?

    Join a game-changing company that is reinventing the way therapiesare developed and commercialized. Created through the merger of two industryleading companies, INC Research and inVentiv Health, we bring together morethan 22,000 clinical and commercial minds to create a better, smarter, fasterway to get biopharmaceutical therapies into the hands of patients who need themmost.

    Evolve in a global company that is always looking for ways to worksmarter and more efficiently as the only fully integrated BiopharmaceuticalAccelerator.

    You'll be supported with comprehensive resources based on today'semerging technologies, data, science and knowledge - instead of practices fromthe past.

    Teaming with some of the most talented professionals in the industry,you'll gain exposure and work in a dynamic environment to over-

    deliver andoutperform. A career with Syneos Health means your everyday work improvespatients’ lives around the world.

    Regular

    Başvuruldu
    Favorilere ekle
    Favorilerden çıkar
    Başvuruldu
    Emailim
    "Devam et" i tıkladığınızda, neuvoo'nun bu formda sağladığınız kişisel verilerinizi, bir neuvoo hesabı oluşturmak ve Gizlilik Politikamız uyarınca e-posta uyarılarımıza abone olmak için toplayıp işlediğini kabul edersiniz. İstediğinizde bu adımları uygulayarak onayınızı çekebilirsiniz .
    Devam et
    Başvuru Formu