CRA II - FSPx Oncology (Lung cancer) - Home Base Madrid

Fortrea

1mo ago

Job
Full-time
Junior Level
Healthcare
Madrid
Remote
Quick Apply

AI generated summary

You need a related degree, 2 years of monitoring experience, knowledge of ICH GCP, respiratory/cardiology experience, and fluency in English and local language. Ready for 60% travel.
You will manage sites, conduct monitoring visits, ensure compliance, verify data integrity, oversee regulatory documents, and assist with project administration and training in oncology trials.

Requirements

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.
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
A minimum of 2 years of Clinical Monitoring experience.
Respiratory and/or Cardiology Monitoring experience.
Must be able to sit at a computer for long periods of time.
Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
Standard office and/or home working environment.
Clinical Research Unit and hospital environment (administrative only).
Risk of eye strain.
Will involve outside of normal office hours as required by the role.
Travel Requirement is 60% of the time (traveling to study sites).

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.
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/e-Clinical 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).
Perform other duties as assigned by management.

FAQs

What is the job title for this position?

The job title for this position is CRA II - FSPx Oncology (Lung cancer) - Home Base Madrid.

What is the primary responsibility of a CRA II?

The primary responsibility of a CRA II includes site management for clinical studies, conducting site monitoring, ensuring compliance with GCP guidelines, and protecting the integrity of data and subjects.

What qualifications are required for this position?

A university or college degree or certification in a related allied health profession is required, along with a minimum of 2 years of clinical monitoring experience and a thorough understanding of ICH GCP Guidelines.

Is travel required for this position?

Yes, travel is required approximately 60% of the time to study sites.

What types of clinical trials will be monitored in this role?

This role focuses on oncology clinical trials, specifically those related to lung cancer.

How important is experience in respiratory or cardiology monitoring for this job?

Experience in respiratory and/or cardiology monitoring is preferred but not explicitly required.

What language proficiency is needed for this role?

Fluency in both the local office language and English, both written and verbal, is required.

What work environment can I expect in this position?

The work environment includes a standard office/home working environment as well as clinical research units and hospitals; it also involves sitting at a computer for long periods and the potential for travel.

What are the physical demands of this job?

The physical demands include sitting for long periods, using hands for keyboarding, and the risk of eye strain, among others.

Does Fortrea offer equal opportunity employment?

Yes, Fortrea is proud to be an Equal Opportunity Employer, promoting diversity and inclusion without tolerance for harassment or discrimination of any kind.

Fortrea

Science & Healthcare

Industry

10,001+

Employees

2023

Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.