Clinical Research Associate / Senior Clinical Research Associate - Northern England

TFS ,
Manchester, Greater Manchester
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Job Description

TFS is a Global CRO headquartered in Sweden. We genuinely believe that Global in mind and local at heart is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent. TFS is currently looking to hire various CRA's to be fully dedicated to an extraordinary sponsor. Key responsibilities * Obtain and maintain essential documentation in compliance with ICH-GCP, TFS procedural documents and local regulations both in trial master file (TMF) and investigator study file (ISF). * Actively participate in local study team meetings. * Contribute to the selection of potential investigators. * Train, support and advise investigators and site staff in study related matters. * Contribute to national investigators meetings. * Initiate, monitor and close study sites in compliance with TFS procedural documents. Share information on patient recruitment and study site progress within local study team. * Drive performance at the sites. Proactively identify study-related issues, solutions and escalate as appropriate. * Update CTMS and other systems with data from centers as per required timelines. * Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites. * Perform source data verification according to SDV plan. * Oversee data query resolution by the site. * Verify accurate and timely reporting of serious adverse events. * Prepare for activities associated with audits and regulatory inspections in liaison with local study delivery team lead and CQM. * Provide the required monitoring visit reports within required timelines. * Work with data management to confirm quality of the study data. * Support and work together with lead CRA, LSM and regulatory affairs to see to timely delivery of study documents for submissions to RA and EC. * Contribute to financial agreements with relevant staff at investigational site in collaboration with lead CRA and/or LSM. * Oversee timely preparation of country specific CSA in collaboration with LSM and/or lead CRA. * Verify compliance with TFSs code of conduct and company policies and procedures relating to people, finance, technology, security and safety, health and environment. * Track and manage agreed payments at study site level. * Participate in training and mentoring of new members of the local study team verifying compliance with ICH/GCP and TFS procedural documents. * Confirm that all study documents are ready for final archiving and sign-off completion of local part of the trial master file. * Contribute to process improvements, knowledge transfer and best practice sharing. * Actively share applicable information that may be relevant to marketing and sales and the MC medical department and in accordance with corporate ethical guidelines. Requirements * Have a Bachelor's degree or equivalent combination of education and experience. * Have substantial experience in field monitoring as a Senior CRA with Contract Research organisation (CRO) experience. * Possess strong problem solving, organizational and time management skills. * Are able to multi-task and attend to detail. * Are great at planning, well organized and can work calmly under pressure. * Have therapeutic area experience in rare diseases Benefits * The opportunity to be part of a friendly, supportive team and work with exciting technologies * Home based flexibility * Competitive salary * Opportunity to work on a complex trial in challenging therapeutic area

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