COVANCEis a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career We are currently recruiting for a Clinical Research Associateready to join our constantly growing FSPx team. This is a full-time, permanent position for our pharmaceutical client s studies.Responsibilities:Site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCPSite management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCPAssures the implementation of project plans as assignedResponsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assignedResponsible for all aspects of site management as prescribed in the project plansGeneral On-Site Monitoring Responsibilities:Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible dataEnsure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policyPrepare accurate and timely trip reportsManage small projects under direction of a Project Manager/Director as assignedServe as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assignedReview progress of projects and initiate appropriate actions to achieve target objectivesOrganize and make presentations at Investigator MeetingsParticipate in the development of protocols and Case Report Forms as assignedParticipate in writing clinical trial reports as assignedInternet with Internal work groups to evaluate needs, resources and timelinesAct as contact for clinical trial supplies and other suppliers (vendors) as assignedResponsible for all aspects of registry management as prescribed in the project plansUndertake feasibility work when requestedConduct, report and follow-up on Quality Control Visits (CQC) when requestedRecruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assignedNegotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assignedComplete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by managementAssist with training, mentoring and development of new employees, e.g. co-monitoringCo-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assignedPerform other duties as assigned by managementRequirements:University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technologyIn lieu of the above requirement, candidates with relevant clinical research experience in pharmaceutical or CRO industries will be consideredThorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countriesThorough understanding of the drug development processFluent in local office language and in English, both written and verbalClinical research monitoring experience (including prestudy, initiation, routine monitoring and closeout visits)Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEPreferably with Oncology monitoring experienceComfortable with frequent travelling to the sites in Singapore and Malaysia
Type : Company job
Role : Junior Executive
Industry : Healthcare/Medical
Salary : Not Disclosed
Covance is one of the world's largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Asia Pacific is a core element in Covance's ability to support the pharmaceutical industry in bringing the miracles of medicine to market sooner. We began operations in the Asia Pacific region in 1988 and today, we continue to grow and now have over 1000 employees in 13 countries across the region.