Clinical Research Associate Belgium - Single Sponsor

Description

Clinical Research Associate Belgium - Single Sponsor Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum helping them navigate complexity anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another our customers and most importantly for those in need. Discover what your 25000 future colleagues already know 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. Why? 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. Job

Responsibilities

We are currently recruiting for an experienced CRA for one of our single-sponsor roles to join the team here in Belgium. The Clinical Research Associate - 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.

Qualification

Requirements

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 Previous monitoring experience in Belgium Must demonstrate good computer skills and be able to embrace new technologies Excellent communication presentation and interpersonal skills Ability to manage required travel for monitoring visits Good knowledge of Dutch French and English Get to know Syneos Health Over the past 5 years we have worked with 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products and over 200 Studies across 73000 Sites and 675000+ Trial patients. No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http//www.syneoshealth.com

Additional Information

Tasks duties and responsibilities as listed in this job description are not exhaustive. The Company at its sole discretion and with no prior notice may assign other tasks duties and job responsibilities. Equivalent experience skills and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above. Further nothing contained herein should be construed to create an employment contract. Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees. 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.

Summary

The Clinical Research Associate II (CRA II) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted recorded and reported in accordance with the protocol Company and Sponsor standard operating procedures (SOPs) ICH-GCP and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently seeking guidance as needed