Clinical Research Associate II

5 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time
Clinical Research Associate II (CRA II)

Apply locations Kuala Lumpur time type Full time posted on Posted Yesterday job requisition id 251235

Summary of Responsibilities:

  • Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
  • Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepares and implements project plans related to Clinical Monitoring responsibilities.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
  • Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
  • Ensures adherence to global quality control and CRA performance metrics.
  • Ensures audit readiness at site level.
  • Acts in the project role of a Lead CRA as assigned.
  • General On-Site Monitoring Responsibilities:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare and submit accurate and timely trip reports.
  • Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
  • Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
  • Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events as assigned.
  • Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
  • Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
  • Attend investigators' meetings (if applicable), project team meetings and teleconferences, and others as needed.
  • Present training content for site initiation.
  • Assist with training of new employees (e.g., co-monitoring).
  • All other duties as needed or assigned.

Qualifications (Minimum Required):

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial 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):

  • A minimum of 2 years of Clinical Monitoring experience.
  • Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
  • Ability to work with minimal supervision.
  • Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Good planning, organization, and problem-solving abilities.
  • Works efficiently and effectively in a matrix environment.

Preferred Qualifications Include:

  • Thorough working knowledge of Fortrea SOPs for site monitoring.
  • One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
  • Phase I monitoring experience.
  • Life Science or Nursing qualification.
  • Specific skills, systems, certifications, and/or licenses preferred.
  • Good attention to detail.
  • Methodical approach to work.
  • Good understanding of medical and clinical research terminology and clinical research processes.
  • Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
  • Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

#J-18808-Ljbffr

  • Clinical Research Associate II Specialist

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    **Job Description:**We are seeking a highly motivated and experienced Clinical Research Associate II to join our team at Fortrea. The successful candidate will be responsible for conducting site monitoring responsibilities for clinical trials, ensuring the protection of subjects, and safeguarding data integrity.Key Responsibilities:Site Management:Verify...

  • Clinical Research Associate Lead

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Clinical Research Associate RoleSyneos Health, Inc. is a leading biopharmaceutical solutions organization accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes.Our Clinical Development model brings the customer and patient to the center of everything we do. We continuously simplify and streamline our...

  • Research Operations Manager

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    **Job Overview:**Fortrea is seeking a highly skilled Clinical Research Associate II to join our team. The successful candidate will be responsible for conducting site monitoring responsibilities for clinical trials, ensuring data integrity, and maintaining quality control.Key Responsibilities:Study Management:Manage study activities and ensure compliance...

  • Clinical Monitoring Lead

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    **Job Description:**We are seeking an experienced Clinical Research Associate II to conduct site monitoring responsibilities for clinical trials. The ideal candidate will have excellent communication skills and be able to work effectively in a matrix environment.Key Responsibilities:Study Coordination:Coordinate study activities with study staff and ensure...

  • Clinical Research Associate

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    Parexel Federal Territory of Kuala Lumpur, MalaysiaClinical Research Associate - FSPParexel Federal Territory of Kuala Lumpur, MalaysiaKey Accountabilities:Start-up (from site identification through pre-initiation):Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.Build relationships...

  • CRA II or SR CRA

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    CRA II or SR CRA (Home base, Sponsor Dedicated)Updated: December 24, 2024Location: Malaysia-Asia Pacific - MYS-Home-BasedJob ID:24007092Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern...

  • Senior Clinical Trial Coordinator

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Senior Clinical Trial Coordinator RoleSyneos Health, Inc. is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success.We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Job Description:The Senior Clinical Research Associate I will perform...

  • Project Manager

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Project Manager Role - Clinical OperationsSyneos Health, Inc. is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success.We focus on simplifying and streamlining our work to make us easier to work with and for.Job Description:The Senior Clinical Research Associate I will perform project management-related tasks,...

  • Senior Clinical Trial Coordinator

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    **Job Summary:**Fortrea is seeking an experienced Clinical Research Associate II to conduct site monitoring responsibilities for clinical trials. The ideal candidate will have a thorough understanding of ICH GCP Guidelines and local regulatory requirements.Key Responsibilities:Study Coordination:Coordinate study activities with study staff and ensure...

  • Research Associate

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    Parexel is a leading global biopharmaceutical services company.Clinical Research Associate Job DescriptionAs a Clinical Research Associate, you will be responsible for managing clinical trials from site identification to close out.You will act as Parexel's direct point of contact with assigned sites, assessing and ensuring overall integrity of study...

  • Regulatory Affairs Specialist

    2 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Syneos Health, Inc. Full time

    Regulatory Affairs Specialist RoleSyneos Health, Inc. is a leading biopharmaceutical solutions organization committed to accelerating customer success.We focus on translating clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Job Summary:The Senior Clinical Research Associate I will perform regulatory...

  • Research Associate

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia IQVIA LLC Full time

    We are seeking a talented Research Associate to join our team at IQVIA LLC.Research AssociateThis role involves assisting in the development of basic market research skills and competencies via on-the-job learnings and other online/offline trainings.Key Responsibilities:Assist in the development of basic market research skills and competencies.Support...

  • Clinical Trial Coordinator Specialist

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Job Overview:The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. This position requires strong organizational and communication skills to ensure timely production of high-quality clinical data.Key Responsibilities:Document and track study activities using...

  • Investment Research Associate

    5 hours ago

    Kuala Lumpur, Kuala Lumpur, Malaysia AHAM Asset Management Berhad Full time

    Investment Research and AnalysisThe Investment Research Associate will be responsible for conducting research on industry trends and developments, and analysing financial data and market trends to inform investment decisions.Key Skills and Qualifications:Bachelor's degree in a relevant discipline, such as finance or economics.At least one year of experience...

  • Clinical Trials Coordinator

    7 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

    In this role, you will play a critical part in the success of our clinical trials.Job DescriptionAs a Clinical Research Associate, you will be responsible for managing clinical trials from start-up to close out.You will work closely with investigators and site staff to ensure that studies are implemented according to protocol.You will assess and ensure...

  • Senior Research Associate Position

    1 day ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Asia School of Business Full time

    Job OverviewThe Senior Research Associate position is a mid-senior level role that requires strong research skills and expertise in data analysis.About the Team:The Asia School of Business (ASB) is a leading educational institution in Kuala Lumpur.The Center for Sustainable Small-owners (CSS) is a research center within ASB, focused on sustainable...

  • Associate Editor

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia CFRA Research Full time

    Associate EditorDepartment: MarketingEmployment Type: Full TimeLocation: Kuala Lumpur, MYDescription CFRA, a global leader in financial intelligence solutions and independent insights, is looking for a full-time proofreader/copy editor to join our global team. Don't miss a great opportunity in a fast-growing firm, with significant influence on the overall...

  • Research Project Administrator

    5 days ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Fortrea Full time

    Company Overview:Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic...

  • Associate Research Director

    1 week ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Ipsos Malaysia Full time

    Associate Research Director (Qualitative)Ipsos Malaysia WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, MalaysiaAbout the Company - Ipsos UU is world's largest qualitative research community and a growth engine for Ipsos globally.About the Role - Work on building the Ipsos brand. Appreciating the vision of Ipsos qualitative and working towards bringing...

  • Research and Development Professional

    1 day ago

    Kuala Lumpur, Kuala Lumpur, Malaysia Asia School of Business Full time

    Research Associate PositionThe Asia School of Business (ASB) and the Center for Sustainable Small-owners (CSS) are seeking a highly skilled Research Associate to join their team.About the Role:This position involves examining the upstream oil palm supply chain using existing quantitative and qualitative data.The successful candidate will be responsible for...