CRA II Madrid Sponsor dedicated.

Experience in oncology clinical trials (lung).

Syneos

Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Why Syneos

Health technical and therapeutic area training; Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.

Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes.

Conducts Source Document

Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

Utilises available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security.

Applies knowledge of GCP/local regulations and organisational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Reconciles contents of the ISF with the Trial Master File (TMF).



Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Participates in integral clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. completes assigned training as required.

For Real World Late

Phase, the CRA II will use the business card title of Site Management Associate II. Knowledge of local requirements for real world late phase study designs. Chart abstraction activities and data collection.

Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager.

Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.





Experience in oncology clinical trials (phases I and lung). Must demonstrate good computer skills and be able to embrace new technologies.

US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession.

You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Get to know Syneos Health. Learn more about Syneos Health. Further, nothing contained herein should be construed to create an employment contract.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers' delivery of important therapies to patients.

Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We're a growing, global company dedicated to advancing our talent past their initial role.

We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients' lives around the world. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.

Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

📌 CRA II_Madrid_Sponsor dedicated. Experience in oncology clinical trials (lung). (Madrid)
🏢 3212 Syneos Health Clinical Spain, S.L.U.
📍 Madrid