Clinical Research Associate

Clinical Research Associate

Posted by WOW Softech

Faridabad

Posted: imported by Jeevika

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RemoteHiring office located in FaridabadPosted: 2 weeks agoOpenings: 1Applicants: 100+Clinical Research AssociateWOW SoftechPosted by WOW SoftechJob description Responsibilities • Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically Assists in the review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities Trains site staff on the EDC system and verifies site computer system. Conducts periodic site file audits to ensure compliance with GCPs standard operating procedures Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner using approved Sponsor forms and reports Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Reviews the quality and integrity of the clinical data through in house review of eCRF data and on-site source verification. Works with sites to resolve data queries Serves as primary contact,coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested Assists with, attends, and may present at Investigator Meetings for assigned studies Performs study close-out visits Serves as mentor for more junior CRAs as well as new CRAs to the project Authorized to request site audits for reasons of validity Performs other duties as requested. KNOWLEDGE, SKILLS AND ABILITIES: Strong knowledge of clinical research process and medical terminology. Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions. Excellent organizational and interpersonal skills. Ability to interact with all levels of staff to coordinate/execute study activities. Ability to handle several priorities within multiple, complex clinical trials. Ability to reason independently and recommend specific solutions in clinical settings. Able to mentor other CRAs on project team and co-monitor as required. Understanding of basic data processing functions, including electronic data capture. Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research. Ability to travel domestically and internationally.Role: Research Associate / Engineer,Industry Type: Clinical Research / Contract Research,Department: Research & Development,Employment Type: Full Time, PermanentRole Category: Pharmaceutical & BiotechnologyEducationUG: B.Sc in Biotechnology, Life ScienceKey SkillsSkills highlighted with ‘‘ are preferred keyskillson- site monitoringCRAClinical ResearchGlobal Clinical trialsClinical Data ManagementClinical TrialsAbout companyAs a global contract research organization (CRO), we offer a diverse slate of clinical development and resource solutions reflecting both full-service CRO and functional service provider (FSP) models. In supporting clinical outsourcing needs for emerging biotech and pharmaceutical companiesmost notably small to mid-size enterprises facing unique challenges we offer our expertise with a presence in key markets including the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.Beware of imposters! Naukri.com does not promise a job or an interview in exchange of money. 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