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Fspx Cra Ii (Guangzhou)

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview

As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and has decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients around the globe.

Essential Job Duties

  1. Site Monitoring: Oversee all aspects of study site monitoring, including routine monitoring, close-out of clinical sites, maintenance of study files, and conducting pre-study and initiation visits. Liaise with vendors as needed.

  2. Site Management: Manage all aspects of site management as outlined in project plans.

  3. On-Site Responsibilities: Ensure that study staff are equipped with the necessary materials and instructions to safely enter patients into the study.

  4. Patient Protection: Verify adherence to informed consent procedures and protocol requirements in compliance with applicable regulatory requirements.

  5. Data Integrity: Conduct careful source document reviews to ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools.

  6. Data Monitoring: Monitor data for any missing or implausible entries.

  7. Resource Management: Utilize Sponsor and Labcorp Drug Development resources efficiently, adhering to SOPs and guidelines, including economical travel management.

  8. Audit Readiness: Maintain audit readiness at the site level.

  9. Travel Requirements: Travel, including air travel, is an essential function of the job.

  10. Reporting: Prepare accurate and timely trip reports.

  11. Registry Management: Oversee all aspects of registry management as specified in project plans.

  12. Feasibility Work: Conduct feasibility assessments when requested.

  13. Quality Control: Participate in and follow up on Quality Control Visits (QC) as required.

  14. Investigator Recruitment: Assist with the recruitment of potential investigators, preparation of EC submissions, and notifications to regulatory authorities.

  15. SAE Tracking: Track and follow up on Serious Adverse Event (SAE) reporting, including report production and narrative follow-ups.

  16. CRF Review: Independently perform CRF reviews, query generation, and resolution against established data review guidelines.

  17. Training: Assist with training new employees, including co-monitoring.

  18. Project Coordination: Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact as assigned.

  19. Additional Duties: Perform other duties as assigned by management.

Requirements

  • A minimum of 1 year of clinical monitoring experience is preferred, or an equivalent combination of education and experience.
  • Ability to independently monitor study sites according to protocol guidelines, SOPs, and local regulations.
  • Strong understanding of Serious Adverse Event (SAE) reporting processes.
  • Excellent planning, organization, and problem-solving abilities.
  • Ability to work with minimal supervision.
  • Strong communication and interpersonal skills.
  • Good analytical and negotiation skills.
  • Computer competency.
  • Fluent in both the local office language and English, both written and verbal.
  • Ability to work effectively in a matrix environment.

Join Us

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact.

Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.

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