CRA | Taiwan
Syneos Health
Taiwan
7天前

WhySyneos Health?

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

minds to create a better, smarter, faster way to get biopharmaceuticaltherapies into the hands

of patients who need them most. Evolve in a globalcompany that is always looking for ways to

work smarter and more efficiently asthe only fully integrated Biopharmaceutical Accelerator.

You'll be supportedwith comprehensive resources based on today's emerging technologies,

data,science and knowledge - instead of practices from the past. Teaming with someof the

most talented professionals in the industry, you'll gain exposure andwork in a dynamic

environment to over-deliver and outperform. A career withSyneos Health means your

everyday work improves patients’ lives around theworld.

Essential Functions : 1.Monitoring

1.Monitoring

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

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

  • Completes and submits monitoring visit reports in accordance with SOP / Work Instructions or Sponsor requirements as agreed in the scope of work.
  • Maintains awareness of key study performance indicators for own sites. Supports subject recruitment and retention strategies.

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

    related issues from contact to contact and anticipates / identifies potential issues and implements corrective actions. Seeks guidance to resolve complex issues.

  • Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements / data collection tools.
  • Serious Adverse Event (SAE) reporting requirements, Investigational Product (IP) management, bio sample management and subject reported outcomes instruments as applicable.

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

  • Extensive travel may be required, 50% to 75% on a regular basis.
  • 2.Subject Rights & Wellbeing Verifies process of obtaining informed consent has been adequately performed and documented for each subject.

    Demonstrates diligence in protecting the confidentiality of each subject. Assesses factors that might affect subject’s safety and clinical data integrity at an investigator site such as protocol deviation / violations and pharmacovigilance issues.

    3.Reporting and Tracking

  • Maintains site performance metrics with guidance and implements action plans for sites not meeting expectations with limited guidance.
  • Maintains current regulatory documentation for assigned sites according to Essential Regulatory Document Guidelines and / or regulatory project plan.
  • Maintains up to date information within the deployed Clinical Trial Management System (CTMS).
  • Audit Maintains all areas of cover as assigned (site & study level) to audit readiness standards and supports preparation for audit and required follow up actions.
  • Demonstrates sufficient time management to achieve required deliverables : consistent on time expense reports, timecard submissions, trip report submissions / finalization, monitoring visit frequency as per Statement of Work (SoW), Clinical Monitoring Plan (CMP).
  • 4.Data Management Uses analytical thinking to review data recorded in source documents for accuracy and completeness and in accordance with the clinical monitoring and associated plans.

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

    Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.

    Performs these tasks routinely and independently, seeking guidance as needed.

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

    Verifies process and identifies any issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released / returned.

    6.Documentation and Record keeping Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

    Reconciles contents of the ISF with the trial master file (TMF). Ensures investigator site is aware of requirement of archiving essential documents in accordance with the local guidelines and regulations.

    Verifies site compliance with requirements for electronic data capture. Performs these tasks routinely and independently seeking guidance as needed.

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

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

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

    9.Attends clinical monitoring / project staff meetings and attends clinical training sessions according to the project specific requirements.

    Other Responsibilities :

    1.Maintains required functional and job specific training.

    2.Performs other work-related duties as assigned.

    3.As a representative of the Company, demonstrates professional attire, attitude and behavior in meetings & teleconferences, site visits and interactions, and interpersonal activities in general.

    Education

  • Bachelor’s Degree required; medical / science / nursingbackground is preferred
  • MS, MA, MBA, MPH desired
  • Experience

  • Minimum of 1 year of clinically-related experience, ofwhich 6 months must be in clinical research monitoring
  • Current in-depth knowledge and understanding ofappropriate therapeutic indications as they relate to the conductof clinical trials
  • Excellent knowledge of regulations governing clinicalresearch, ICH / GCP Guidelines and / or federal regulations,and applicable local regulations
  • Experience in on-site monitoring of investigational drugor device trials is required
  • Disclaimer :

    Tasks, duties, and responsibilities as listed in this job description are notexhaustive. The Company, at its sole discretion and with no prior notice, mayassign other tasks, duties, and job responsibilities.

    Equivalent experience,skills, and / or education will also be considered so qualifications ofincumbents may differ from those listed in the Job Description.

    The Company, atits sole discretion, will determine what constitutes as equivalent to thequalifications described above. Further, nothing contained herein should beconstrued to create an employment contract.

    Occasionally, requiredskills / experiences for jobs are expressed in brief terms. Any languagecontained herein is intended to fully comply with all obligations imposed bythe legislation of each country in which it operates, including theimplementation of the EU Equality Directive, in relation to the recruitment andemployment of its employees.

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