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Syneos Health
,
London, Greater London
Clinical Support Associate - London
Overview
20001872 Clinical Support Associate Office based in White City, London Permanent Job Purpose: • Provides a central, key support function across multi-disciplinary teams; including Operations and Project Managers in the management of clinical trials. Major Accountabilities: • Supports Clinical Project Teams to ensure good quality output for in-house clinical functions. • Works closely with In-House Set Up Team and Project Manages to improve rapid study start up and reduce study start up timelines. • Proactively assists Project Managers in running of clinical studies and supports field based CRA teams to maximise study performance. • Has a good knowledge of ethics / R&D processes to ensure owned studies are on track. • Key, pivotal member of the clinical team to ensure support and communication between project teams. • Central point of contact for study related issues across medical and other departments. • Ensures all Safety Information for specified trials are distributed to investigational sites according to SOPs and NIPs and prevailing law. • Performs site visits when requested to assist with monitoring activities in the field, unblinded monitoring and drug accountability to improve productivity within the department. • Is responsible for ensuring that Investigator payments are made on time and are accurately processed and has an excellent knowledge of finance systems. • Ensures all trial documentation is created, distributed, maintained and tracked, using electronic storage facilities where necessary, in accordance with SOPs in order to ensure smooth and timely running of trials. • Ensures that essential trial documentation is filed and up kept to regulatory requirements. • Responsible for end of trial site file and TMF reviews when requested • Is responsible for the production of study aids and clinical documentation / manuals, e.g. Patient ID Cards, Diary Cards, Patient Information Sheets/Consent Forms for specified trials to a high quality standard. • Professionally sets up project tracking tools and ensures they are used efficiently within the team. • Assists Clinical Project Managers in the organisation of investigator meetings when necessary. • Ensures essential databases are maintained for specified trials. • Up keeps relevant tracking tools for managing the In-House and Off site archiving management service. • Liaises with investigational site staff regarding end of trial achieving requirements and documents effectively. Qualifications The ideal candidate will need the following experience / skills to be considered: • A degree in a scientific or health care discipline or equivalent desirable but not essential. • Desired experience within the Pharmaceutical Industry / CRO environment with a good knowledge of Clinical Research processes including ICH GCP. • Excellent communication skills and an ability to multi task. • PC Literate - Intermediate Word, Excel, PowerPoint, Lotus Notes. We have a comprehensive benefits package and offer highly competitive remuneration. Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. If you have the required experience for this position and are eligible to work in the required location then please apply. To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/ LI-LA1 Disclaimer: 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.