Cra Ii - Oncology

2+ years

Not Disclosed

Remote - Europe

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

Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development. We provide pharmaceutical, biotechnology, and medical device customers with a diverse range of clinical development, patient access, and technology solutions across over 20 therapeutic areas. Operating in more than 90 countries, Fortrea is committed to transforming drug and device development for partners and patients worldwide.

Job Description

This role is for upcoming future opportunities at Fortrea. The Site Manager is responsible for site management of clinical studies in accordance with Fortrea’s Standard Operating Procedures, ICH GCP guidelines, applicable project plans, and sponsor requirements.

Key Responsibilities

Site Management: Oversee clinical study site activities, ensuring adherence to Fortrea’s SOPs and GCP guidelines. Responsibilities include pre-study, site initiation, process monitoring, routine monitoring, and close-out visits.
Project Planning: Prepare and implement project plans related to clinical monitoring responsibilities, verifying study training records and site regulatory documents throughout the trial.
Data Integrity: Safeguard data integrity through source document review, verification, query generation, and resolution against established guidelines in Fortrea’s data management systems.
Investigational Product Oversight: Ensure accurate inventory and accountability of the study investigational product, storing materials securely per protocol requirements.
Quality Control: Maintain adherence to global quality control and CRA performance metrics, ensuring audit readiness at the site level.
Lead CRA Role: Act as the project lead CRA as assigned, coordinating the site monitoring process.

General On-Site Monitoring Responsibilities

Ensure study staff have the necessary materials and instructions to safely enroll subjects, protecting study participants by verifying compliance with screening and informed consent procedures.
Monitor source data for completeness and accuracy, identifying deficiencies and initiating corrective actions as needed.
Perform required monitoring tasks efficiently, managing travel expenses in accordance with Fortrea’s travel policy.
Prepare and submit accurate and timely trip reports, and conduct eCRF reviews and source data verification independently.
Assist with project administration, including recruiting investigators and collecting necessary documentation.
Maintain study-specific trial management tools and track investigational product shipments and serious adverse events.
Collaborate closely with the study team to align monitoring with critical study timelines, ensuring deliverables are met.
Attend investigators' meetings and project team discussions, presenting training content as required.
Support the training of new employees through co-monitoring and other duties as assigned.

Qualifications

University or college degree, or certification in a related allied health profession (e.g., nursing licensure). Equivalent experience may be considered.
Thorough understanding of ICH GCP guidelines and local regulatory requirements.
Knowledge of monitoring procedures and a basic understanding of the clinical trial process.
Fluent in the local office language and English, both written and verbal.

Experience

A minimum of 2 years of clinical monitoring experience, with a relevant university or college degree or allied health certification.

Physical Demands / Work Environment

Ability to sit at a computer for long periods and use hands for typing and handling tools, including a computer keyboard, for up to 8 hours per day.
Standard office or home working environment with potential exposure to clinical research units and hospitals.
Will involve travel (60% of the time) to study sites and may require work outside normal office hours.

Join Us

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative workspace 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 made 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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