Cra Ii
hace 3 semanas
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.This role is for upcoming future opportunities that may arise at Fortrea.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/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.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.Experience (Minimum Required):* University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).AND* A minimum of 2 years of Clinical Monitoring experience.Physical Demands / Work Environment:* 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)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 ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.
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Cra Barcelona – Regional Monitoring
hace 1 mes
Barcelona, España Resourcing Life Science A tiempo completoCompany DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a CRA / Clinical Research Associate Regional Monitoring in Barcelona.Job OverviewMonitoring...
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Cra Barcelona – Regional Monitoring
hace 2 meses
Barcelona, España Resourcing Life Science A tiempo completoCompany DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a CRA / Clinical Research Associate Regional Monitoring in Barcelona.Job Overview- Monitoring...
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Cra Barcelona – Regional Monitoring
hace 1 mes
Barcelona, España Resourcing Life Science A tiempo completoCompany Description Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a CRA / Clinical Research Associate Regional Monitoring in Barcelona.Job Overview Monitoring...
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Cra Barcelona – Regional Monitoring
hace 2 meses
Barcelona, España Resourcing Life Science A tiempo completoCompany Description Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a CRA / Clinical Research Associate Regional Monitoring in Barcelona.Job Overview Monitoring...
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Cra Ii
hace 6 meses
Barcelona, España ICON A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
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Cra Barcelona – Regional Monitoring
hace 3 meses
Barcelona, España Resourcing Life Science A tiempo completoCompany DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a CRA / Clinical Research Associate Regional Monitoring in Barcelona.Job OverviewMonitoring...
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Cra Ii Barcelona. Sponsor Dedicated
hace 6 meses
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Clinical Research Associate II** Syneos 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 market realities. Our Clinical Development model brings the customer and the...
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Cra Ii
hace 4 semanas
Barcelona, España Fortrea A tiempo completo.As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations...
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Cra Ii
hace 1 mes
Barcelona, España Syneos Health, Inc. A tiempo completoCRA II - Sponsor Dedicated - Cardiovascular - Madrid, Spain Updated: October 16, 2024 Location: Spain-Europe - ESP-Home-Based (Madrid) Job ID: 24005547 Syneos 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...
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Cra Ii Barcelona Or Madrid. Sponsor Dedicated.
hace 3 semanas
Barcelona, España Syneos Health, Inc. A tiempo completoCRA II Barcelona or Madrid. Sponsor dedicated. Updated: October 31, 2024Location: Spain-Europe - ESP-Barcelona-571-Av.DiagonalJob ID: 24005926Syneos 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...
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Cra Ii Barcelona Or Madrid. Sponsor Dedicated.
hace 3 semanas
Barcelona, España Syneos Health, Inc. A tiempo completoCRA II Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Barcelona-571-Av.DiagonalJob ID:24005926Syneos 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...
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Cra Ii Barcelona Or Madrid. Sponsor Dedicated.
hace 3 semanas
Barcelona, España Syneos Health, Inc. A tiempo completoCRA II Barcelona or Madrid.Sponsor dedicated.Updated: October 31, 2024 Location: Spain-Europe - ESP-Barcelona-571-Av.Diagonal Job ID: 24005926 Syneos 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...
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Cra Ii
hace 6 meses
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **Clinical Research Associate II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...
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CRA II Barcelona or Madrid. Sponsor dedicated.
hace 3 semanas
Barcelona, España Syneos Health, Inc. A tiempo completoCRA II Barcelona or Madrid. Sponsor dedicated. Updated: October 31, 2024Location: Spain-Europe - ESP-Barcelona-571-Av.DiagonalJob ID: 24005926 Syneos 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...
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Clinical Research Associate Ii
hace 6 meses
Barcelona, España Ora A tiempo completo**POSITION TITLE**: Clinical Research Associate II **DEPARTMENT**:Ora Europe **LOCATION**: Remote, Spain **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ - _At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and...
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Cra Ii Barcelona Or Madrid. Sponsor Dedicated.
hace 3 semanas
Barcelona, España Syneos Health, Inc. A tiempo completo.CRA II Barcelona or Madrid. Sponsor dedicated. Updated: October 31, 2024Location: Spain-Europe - ESP-Barcelona-571-Av.DiagonalJob ID: 24005926 Syneos 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...
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Cra Ii Barcelona Or Madrid. Sponsor Dedicated.
hace 3 semanas
Barcelona, España Syneos Health, Inc. A tiempo completo.CRA II Barcelona or Madrid. Sponsor dedicated. Updated: October 31, 2024Location: Spain-Europe - ESP-Barcelona-571-Av.DiagonalJob ID: 24005926Syneos 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...
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Cra Ii Barcelona Or Madrid. Sponsor Dedicated.
hace 3 semanas
Barcelona, España Syneos Health, Inc. A tiempo completo.CRA II Barcelona or Madrid. Sponsor dedicated.Updated: October 31, 2024Location: Spain-Europe - ESP-Barcelona-571-Av.DiagonalJob ID:24005926Syneos 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...
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Cra Ii Barcelona Or Madrid. Sponsor Dedicated.
hace 3 semanas
Barcelona, España Syneos Health Healthcare Careers A tiempo completo.CRA II Barcelona or Madrid. Sponsor dedicated. Syneos Health Healthcare Careers – Barcelona, BarcelonaSyneos 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 market realities.Our Clinical...
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CRA II Barcelona or Madrid. Sponsor dedicated.
hace 4 semanas
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completoDescription Clinical Research Associate II Syneos 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 market realities. Our Clinical Development model brings the customer and the patient to...
