Clinical research Associate (CRA)

Job Description

A special client of ours is looking to grow their team of Clinical Research Associates in Abu Dhabi. The clinical trials are diversified across multiple therapeutic areas and they aim to provide life changing and innovative treatments.Client DetailsA newly launched clinical research organisation in the UAE that provides multiple services across health care. Their aim is to facilitate the highest standard of clinical trials globally that can service the unique populations of the region and benefit communities worldwide.With their expertise in data research, project management, testing, and trials, enables pharmaceutical companies to develop new medicines and drugs in a cost-effective manner, which will allow them to enter new products to market more efficiently.DescriptionParticipation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPsSite selection and qualification evaluation under supervision of senior personnelAssists during a study set-up regarding a submission and approval process and preparation of the documentation as per all applicable local requirementsCollects all ECs requirements per allocated studiesCoordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific studyMonitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance. Strictly follows everything stipulated under ICH-GCP, point 5.18Review and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DMReporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferencesEnsuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc)Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sitesProviding any requested internal progress reports and completion of the relevant filesEnsuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasksFirst line of communication for any study related issues arisen by sites for studies lead by him/ herExecute any activities in compliance with applicable SOPs, instructions, and principlesResponsible for issues escalation following the proper escalation pathwayProvide internal training to the team on specific topicProfileBSc degree in life scienceResponsible for at least 3 Interventional Clinical trials covering all trial cycleExcellent decision making and organizational skills, time management and team working skillsProficient in MS Office (Excel, Access, Word etc.)Good research and organizational abilitiesGood knowledge of GCP with certificationGood Documentation skillsGood management and leadership skillsGreat organizational, planning and multitasking skillsDemonstrated superior communication skills in cross-cultural environmentsAbility to prioritize responsibilities and work effectively in a matrix environment with tight deadlines.Job OfferCompetitive salary and family inclusive benefits!

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