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Cra Ii - Fspx - Oncology - Portugal

2+ years
Not Disclosed
10 Nov. 21, 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

Explore Future Opportunities with Fortrea – A Global Leader in Clinical Research

Fortrea is a premier global contract research organization (CRO) renowned for its scientific rigor and clinical development expertise. We deliver innovative clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, we are transforming drug and device development for both partners and patients worldwide.

This role is for future opportunities at Fortrea, where we are actively seeking motivated individuals to join our team and help drive the success of clinical studies across the globe.

Role Overview:

As part of our clinical team, you will be responsible for site management and monitoring clinical studies in line with Fortrea’s Standard Operating Procedures (SOPs), ICH GCP Guidelines, and Sponsor requirements. You will ensure the safety of study participants, the integrity of data, and compliance with regulatory guidelines while maintaining high quality standards throughout the clinical trial process.

Key Responsibilities:

  • Manage and monitor clinical sites throughout the study lifecycle, including pre-study, initiation, routine monitoring, and close-out visits.
  • Ensure adherence to informed consent procedures, protocol requirements, and applicable regulatory standards to protect study participants.
  • Review and verify source documents, ensuring accurate and complete data entry and query resolution.
  • Ensure the integrity of study data through careful review and compliance checks, including generating corrective action where necessary.
  • Maintain regulatory documents, ensuring they are up to date and compliant throughout the trial.
  • Oversee Investigational Product (IP) accountability and storage in compliance with protocol requirements.
  • Prepare for audits and ensure site readiness for inspections.
  • Travel to various study sites, with travel requirements up to 60% of the time.

Qualifications:

  • University degree or certification in a related allied health profession (e.g., nursing licensure), or equivalent experience.
  • Minimum of 2 years of Clinical Monitoring experience, with a thorough understanding of ICH GCP guidelines and local regulatory requirements.
  • Fluent in English (both written and verbal) and proficient in the local office language.

Physical Demands and Work Environment:

  • Must be able to sit for long periods and use a computer keyboard for up to 8 hours a day.
  • Standard office, home office, and clinical research unit environments.
  • Requires travel (up to 60%) to clinical study sites, and may involve irregular hours as needed.

Why Join Fortrea?

Fortrea is passionate about empowering creative thinkers and problem-solvers who share our commitment to overcoming barriers in clinical trials. By joining our exceptional team, you will contribute to accelerating the development of life-changing therapies that impact patients globally. We foster a collaborative, growth-oriented environment where you can make a meaningful difference and advance your career.

Equal Opportunity Employer:

Fortrea is an Equal Opportunity Employer (EOE/AA). We value diversity and inclusion in the workforce and do not tolerate harassment or discrimination. We make employment decisions based on business needs and individual qualifications, ensuring fairness across all protected characteristics. We encourage all qualified individuals to apply.

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