CRA bij de sponsor - Nederland

Syneos Health, Inc.; Nederland; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. is seeking an experienced Clinical Research Associate to join our Netherlands team. This role focuses on on-site and remote monitoring to ensure ICH-GCP compliance and robust data integrity across sponsor programs.

You will conduct site qualification, initiation, monitoring visits, and data verification, collaborating with site staff and global teams. Dutch and English fluency is required, and some travel within the Netherlands may be needed.

Formación

• Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
• Solid knowledge of Good Clinical Practice (ICH-GCP) and regulatory requirements.
• Excellent communication and interpersonal skills; fluent in Dutch and English.
• Prior monitoring experience in the Netherlands.

Responsabilidades

• Perform site qualification, initiation, monitoring, and close-out visits (on-site or remote).
• Assess site performance, ensure protocol compliance and regulatory standards.
• Conduct Source Data Review and verify CRF data accuracy and completeness.
• Maintain ISF/TMF documentation and support audit readiness.
• Assist in subject recruitment and retention activities; manage tracking systems.

Conocimientos

GCP knowledge

Communication skills

Dutch language

English language

Monitoring experience NL

Educación

Bachelor’s degree or RN

Descripción del empleo

CRA bij de sponsor - NederlandThis website uses cookies to enhance user experience and to analyze performance and traffic on our website. We also share information about your use of our site with our social media, advertising and analytics partners. Privacy Notice# Work Here Matters Everywhere## CRA bij de sponsor - NederlandApply: Remote (Pre-Approved): NLD-Remote: Full time: Posted Today: 25114488CRA bij de sponsor - NederlandSyneos 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 the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:**WORK HERE MATTERS EVERYWHERE**Why Syneos Health* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.* We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.**Job Responsibilities**For one of our single sponsor partnerships we are currently recruiting for an experienced CRA to join the team here in The Netherlands. * 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. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.* Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. 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. Utilizes 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. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.* Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. 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. Supports subject/patient recruitment, retention and awareness strategies. 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. Must be able to quickly adapt to changing priorities to achieve goals / targets.* May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements* Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global 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.* Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. Qualifications:* Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements* Must demonstrate good computer skills and be able to embrace new technologies* Previous monitoring experience in The Netherlands* Excellent communication, presentation and interpersonal skills* Fluency in Dutch and English* Ability to manage required travel for monitoring visits throughout the country.# We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.