[Remote] Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Novotech is a global full-service clinical Contract Research Organization (CRO) recognized for its leadership in clinical research and scientific advisory services. The Clinical Research Associate (CRA) is responsible for ensuring the rights and wellbeing of trial participants and for the accuracy and completeness of trial data, acting as the primary contact between investigational sites and the company.ResponsibilitiesCRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trialsFoster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelinesProvide mentorship to junior staff and can also provide support to the line manager or project manager as per requestResponsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PMIn collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as neededIn collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials. • Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as requiredMonitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co monitoring visits. Visits can be conducted either onsite or remote as per CMPEnsure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptlyVerify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring PlanEnsure all study drug is appropriately stored, dispensed, accountedSkillsGraduate in a clinical or life sciences-related fieldRelevant experience/qualifications in allied professions may also be consideredMust have good time management skillsAttention to detailBe able to work well in a teamBe computer literateAt least 2-3 years of Clinical Research Associate experience in the Clinical industryPreferably experience of working in the research, pharmaceutical industry or a related field per job level as followsBenefitsFlexible working optionsPaid parental leave for both parentsFlexible leave entitlementsWellness programsOngoing development programsAccess to mentorship opportunitiesProfessional development programsA dynamic communityNovoLife, our flexible benefits frameworkCompany OverviewNovotech is internationally recognized as a leading regional full-service CRO. It was founded in 1996, and is headquartered in Sydney, New South Wales, AUS, with a workforce of 1001-5000 employees. Its website is http://www.novotech-cro.com/.