CRA I
Syneos Health
Turkey
son 2 gün

JOB SUMMARY

The Clinical Research Associate I (CRA I) willperform 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-

GCPand / or all applicable local and federal regulatory requirements. Requiresguidance and oversight, while developing an understanding of the drugdevelopment and commercialization process.

JOB RESPONSIBILITIES

  • Performs sitequalification, site initiation, interim monitoring, site management activities andclose-out visits (performed on-
  • site or remotely) ensuring regulatory, ICH-GCPand / or Good Pharmacoepidemiological 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 with guidance 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.

  • For 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 project 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 assigned activities,understands project scope, budgets, and timelines; manages site-levelactivities / communication to ensure project objectives, deliverables andtimelines are met.
  • Must be able toquickly adapt, with the oversight of the Lead CRA, to changing priorities toachieve goals / targets.

  • May act as primaryliaison with project site personnel, or in collaboration with another CRA orCentral Monitoring Associate (CMA).
  • Ensures all assigned sites and project-specific site team members aretrained and compliant with applicable 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.
  • For Real World LatePhase, the CRA I will use the business card title of Site Management AssociateI.Additional responsibilities include :
  • oSite support throughout the study lifecycle from site identificationthrough close-out

    oKnowledge of local requirements for real world late phase study designs

    oChart Abstraction activities and data collection

    oCollaboration with Sponsor affiliates,medical science liaisons and local country staff

    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 regulatory requirements
  • 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 SyneosHealth?

    Join a game-changingcompany that is reinventing the way therapies are developed and commercialized.Created through the merger of two industry leading companies, INC Research andinVentiv Health, we bring together more than 22,000 clinical and commercial mindsto create a better, smarter, faster way to get biopharmaceutical therapies intothe hands of patients who need them most.

    Evolve in a global company that isalways looking for ways to work smarter and more efficiently as the only fullyintegrated Biopharmaceutical Accelerator.

    You'll be supported withcomprehensive resources based on today's emerging technologies, data, scienceand knowledge - instead of practices from the past.

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

    deliver and outperform. A career with Syneos Healthmeans your everyday work improves patients’ lives around the world.

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