Talent.com
This job offer is not available in your country.
Senior Clinical Research Associate I (SCRA1), FSP model

Senior Clinical Research Associate I (SCRA1), FSP model

FortreaKuala Lumpur, Kuala Lumpur, Malaysia
30+ days ago
Job description

Overview

The Senior Clinical Research Associate I (SCRA I), FSP model, is responsible for site monitoring and site management in accordance with Fortrea, Sponsor Standard Operating Procedures, and regulatory guidelines. The Senior CRA I ensures the implementation of project plans, may lead projects of limited scope, and may have line management responsibilities or act in the project role of Local Project Coordinator or Lead CRA as assigned.

Responsibilities

  • Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
  • Responsible for all aspects of site management as prescribed in the project plans.

Qualifications (Minimum Required)

  • University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
  • In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
  • Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
  • Thorough understanding of the drug development process.
  • Fluent in local office language and in English, both written and verbal.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Experience (Minimum Required)

  • Typically three (3) years of clinical onsite monitoring experience.
  • Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.
  • Advanced site monitoring skills.
  • Advanced study site management skills.
  • Advanced registry administration skills.
  • Ability to work with minimal supervision.
  • Valid Driver's License.
  • Physical Demands / Work Environment

  • Travel requirements : 60-80%
  • Learn more about our EEO & Accommodations request here.

    Seniority level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

  • Research, Analyst, and Information Technology
  • #J-18808-Ljbffr

    Create a job alert for this search

    Associate Associate • Kuala Lumpur, Kuala Lumpur, Malaysia

    Related jobs
    • Promoted
    • New!
    Partner Sales Director - IHV Alliances

    Partner Sales Director - IHV Alliances

    CanonicalSepang, Selangor, Malaysia
    Canonical Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia.Join or sign in to find your next job.Partner Sales Director - IHV Alliances. Canonical Kuala Lumpur, Federal Territory of Kuala L...Show moreLast updated: 17 hours ago
    • Promoted
    Payroll Risk & Compliance Lead - APAC

    Payroll Risk & Compliance Lead - APAC

    RemoteKuala Selangor, Kuala Selangor, Malaysia
    Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease.We make it possible for businesses of all sizes to recruit, pay, and manage internatio...Show moreLast updated: 27 days ago
    • Promoted
    Senior Statistician

    Senior Statistician

    OPISKuala Selangor, Malaysia
    Due to our ongoing global expansion, we have a great opportunity for a.The Senior Statistician reports to the Biostatistics Coordinator, serves as the primary point of contact to the study team for...Show moreLast updated: 6 days ago
    • Promoted
    • New!
    Senior Associate, Innovation

    Senior Associate, Innovation

    RHB Banking GroupKuala Lumpur, Kuala Lumpur, Malaysia
    We are seeking an experienced and future-focused Senior Associate to join the Group Strategy team at RHB Banking Group.Operating at a senior individual contributor level, you will play a key role i...Show moreLast updated: 17 hours ago
    CRA II

    CRA II

    ICONKuala Lumpur, Malaysia
    ICON plc is a world-leading healthcare intelligence and clinical research organization.We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join u...Show moreLast updated: 21 days ago
    Senior AI Research Engineer, Model Inference (100% Remote)

    Senior AI Research Engineer, Model Inference (100% Remote)

    Tether Operations LimitedPuchong, 10, MY
    Join Tether and Shape the Future of Digital Finance.At Tether, we’re not just building products, we’re pioneering a global financial revolution. Our cutting-edge solutions empower businesses—from ex...Show moreLast updated: 6 days ago
    • Promoted
    Clinical Integration Specialist

    Clinical Integration Specialist

    ResMedKuala Lumpur, Malaysia
    The Medical Affairs team collaborates with the leaders of Sleep, Respiratory Care, SaaS, ResMed Healthcare, and Asia Growth Markets to ensure our work, especially our clinical research and market a...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Data Partner- Math- Chinese - Remote- Global

    Data Partner- Math- Chinese - Remote- Global

    TELUS DigitalKlang City, Selangor, Malaysia
    Data Partner- Math- Chinese - Remote- Global.Join TELUS Digital as a Data Partner to design advanced, domain-specific questions and solutions. The role involves creating challenging problem sets tha...Show moreLast updated: 17 hours ago
    • Promoted
    Clinical Integration Specialist

    Clinical Integration Specialist

    ResmedKuala Lumpur, Kuala Lumpur, Malaysia
    Resmed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia.Join or sign in to find your next job.Clinical Integration Specialist. Resmed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malays...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Senior Software Engineer, AI Model serving - Kuala Lumpur, Malaysia

    Senior Software Engineer, AI Model serving - Kuala Lumpur, Malaysia

    SpeechifySepang, Selangor, Malaysia
    Senior Software Engineer, AI Model serving - Kuala Lumpur, Malaysia.Speechify Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia. Join or sign in to find your next job.Senior Software Enginee...Show moreLast updated: 17 hours ago
    Associate Research Manager, Third-Party Due Diligence

    Associate Research Manager, Third-Party Due Diligence

    Control RisksKuala Lumpur, Federal Territory of Kuala Lumpur, MY
    Quick Apply
    Our third-party due diligence (VANTAGE) team assess our clients’ current, former or potential counterparties, looking for any issues that might pose a reputational or business risk to them, whereve...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Application Specialist

    Clinical Application Specialist

    PhilipsPetaling Jaya, Selangor, Malaysia
    Clinical Application Specialist.Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable thr...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Product Specialist (Surgical)

    Senior Product Specialist (Surgical)

    Baxter International Inc.Petaling Jaya, Selangor, Malaysia
    Senior Product Specialist (Surgical).This is where your work makes a difference.At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a heal...Show moreLast updated: 30+ days ago
    • Promoted
    Risk Consulting - Financial Services Risk Management (FSRM), Associate / Senior Associate

    Risk Consulting - Financial Services Risk Management (FSRM), Associate / Senior Associate

    EYKuala Lumpur, Kuala Lumpur, Malaysia
    At EY, we’re all in to shape your future with confidence.We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.Join EY and help ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    TelecontinentKuala Selangor, Kuala Selangor, Malaysia
    Senior Supplier Quality Engineer.Get AI-powered advice on this job and more exclusive features.This range is provided by Telecontinent. Your actual pay will be based on your skills and experience — ...Show moreLast updated: 27 days ago
    • Promoted
    RIO Execution Hub Sr. Associate

    RIO Execution Hub Sr. Associate

    PfizerKuala Lumpur, Malaysia
    Associate page is loaded## RIO Execution Hub Sr.Malaysia - Kuala Lumpurtime type : .The RIO Execution Hub Sr Associate is responsible for providing regulatory support to the International country and...Show moreLast updated: 6 days ago
    • Promoted
    Clinical Science Associate

    Clinical Science Associate

    Sanofi USPetaling Jaya, Malaysia
    About the Job We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological diso...Show moreLast updated: 6 days ago
    • Promoted
    Climate Risk Modelling - Experienced Associate or Senior Associate

    Climate Risk Modelling - Experienced Associate or Senior Associate

    EYKuala Lumpur, Kuala Lumpur, Malaysia
    Climate Risk Modelling - Experienced Associate or Senior Associate.EY Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia. The Covid-19 pandemic is creating seismic challenges around the world...Show moreLast updated: 30+ days ago