CRA | Taiwan
Syneos Health
Taiwan- TWN--
10天前

Essential Functions : 1.Monitoring

1.Monitoring

  • Assurescompliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (GCP)guidelines, and Company and Sponsor SOPs.
  • Criticallyevaluates adequacy of investigator sites (qualifications, facilities, equipmentand performance). Performs all tasks required for onsite / remote monitoringincluding but not limited to source document review (SDR) and source documentverification (SDV).
  • Plans and conducts study initiation visits for investigatorsites. Applies planning techniques for monitoring visits to ensure efficientand effective monitoring.

    Plans and conducts study close-out visits forinvestigator sites. Manages and prioritizes workload effectively.

  • Completesand submits monitoring visit reports in accordance with SOP / Work Instructionsor Sponsor requirements as agreed in the scope of work.
  • Maintains awareness ofkey study performance indicators for own sites. Supports subject recruitmentand retention strategies.

    Updates study and subject status information.Documents and tracks the resolution of all outstanding site-specificprotocol-

    related issues from contact to contact and anticipates / identifiespotential issues and implements corrective actions. Seeks guidance to resolvecomplex issues.

  • Ensuresall assigned sites are trained and compliant with requirements of the studyprotocol, informed consent process, data collection requirements / datacollection tools.
  • Serious Adverse Event (SAE) reporting requirements,Investigational Product (IP) management, bio sample management and subjectreported outcomes instruments as applicable.

    Follows standard process fordocumentation of site contacts (visits, phone, email etc.).

  • Extensive travel may be required, 50% to 75% on aregular basis.
  • 2.SubjectRights & Wellbeing Verifies process of obtaining informed consent has beenadequately performed and documented for each subject.

    Demonstrates diligence inprotecting the confidentiality of each subject. Assesses factors that mightaffect subject’s safety and clinical data integrity at an investigator sitesuch as protocol deviation / violations and pharmacovigilance issues.

    3.Reportingand Tracking

  • Maintainssite performance metrics with guidance and implements action plans for sitesnot meeting expectations with limited guidance.
  • Maintainscurrent regulatory documentation for assigned sites according to EssentialRegulatory Document Guidelines and / or regulatory project plan.
  • Maintainsup to date information within the deployed Clinical Trial Management System (CTMS).
  • Audit Maintains all areas of cover as assigned (site & study level) to auditreadiness standards and supports preparation for audit and required follow upactions.
  • Demonstratessufficient time management to achieve required deliverables : consistent on timeexpense reports, timecard submissions, trip report submissions / finalization,monitoring visit frequency as per Statement of Work (SoW), Clinical MonitoringPlan (CMP).
  • 4.DataManagement Uses analytical thinking to review data recorded in source documentsfor accuracy and completeness and in accordance with the clinical monitoringand associated plans.

    Verifies clinical data entered in the case report form(CRF) is accurate and complete. Applies query resolution techniques remotelyand on site and provides guidance to site staff as necessary, driving queryresolution to closure within agreed timelines.

    Utilizes available hardware and software to support the effectiveconduct of the clinical study data review and capture.Performs these tasks routinely andindependently, seeking guidance as needed.

    5.InvestigationalProduct Performs IP inventory, reconciliation and reviews storage and security.Verifies the IP has been dispensed and administered to subjects according tothe protocol.

    Verifies process and identifies any issues or risks associatedwith blinded or randomized information related to IP. Applies knowledge ofGCP / local regulations and organizational procedures to ensure IP isappropriately (re)labelled, imported and released / returned.

    6.Documentationand Record keeping Routinely reviews the Investigator Site File (ISF) foraccuracy, timeliness and completeness.

    Reconciles contents of the ISF with thetrial master file (TMF). Ensures investigator site is aware of requirement ofarchiving essential documents in accordance with the local guidelines andregulations.

    Verifies site compliance with requirements for electronic datacapture. Performs these tasks routinely and independently seeking guidance asneeded.

    7.Communication Maintainseffective, accurate, and timely communication with site staff and project team,ensures appropriate issue escalation.

    Seeks guidance to resolve more complextasks. Uses the appropriate mode of communication in relaying information.Participates in global conference calls and meetings to review progress ofongoing clinical trials.

    8.Prepares for and attends Investigator Meetingsand / or sponsor face to face meetings.

    9.Attends clinical monitoring / project staff meetingsand attends clinical training sessions according to the project specificrequirements.

    OtherResponsibilities :

    1.Maintains required functional and job specifictraining.

    2.Performs other work-related duties as assigned.

    3.Asa representative of the Company, demonstrates professional attire, attitude andbehavior in meetings & teleconferences, site visits and interactions, andinterpersonal activities in general.

    Requirements :

  • BA / BS degree in science / health care field or nursing degree orequivalent combined education and experience.
  • Moderate experience as a CRA in directly relatable sitemanagement, or clinical site conduct experience.
  • Moderate understanding ofSOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
  • On siteexperience : signed off to independently conduct at least two types of visits;PSSV, SIV, IMV, COV.
  • Experience of Observation / Training visit on all types ofvisits. Competent in independent drug accountability. Competent in independent investigatorsite file review.
  • Demonstrates understanding of all Essential Documents andtheir collection and maintenance.
  • Off-site experience : familiarity with basiccategory of Clinical Monitoring Associate tasks. Ability to understand / guidesite staff to execute on clinical protocols.
  • Understanding of local regulatory,safety, and GCP. Demonstrate proficiency in navigation within : CTMS systems,Data Platforms for projects, Microsoft Suite : Excel, Word, Power Point,Outlook, Site EMR systems.
  • Model professional communication in both written andverbal interactions.

  • Demonstrate sufficient time management to achieve requireddeliverables.
  • Ability to handle multiple tasks to meet deadlines in a dynamicenvironment.
  • Disclaimer :

    Tasks, duties, and responsibilities as listed in this jobdescription are not exhaustive. TheCompany, at its sole discretion and with no prior notice, may assign othertasks, duties, and job responsibilities.

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

    The Company, at its solediscretion, will determine what constitutes as equivalent to the qualificationsdescribed above. Further,nothing contained herein should be construed to create an employmentcontract.

    Occasionally, requiredskills / experiences for jobs are expressed in brief terms. Any language contained herein is intended tofully comply with all obligations imposed by the legislation of each country inwhich it operates, including the implementation of the EU Equality Directive,in relation to the recruitment and employment of its employees.

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