Remote Clinical Research Associate II - Oncology - Southeast, South, or

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to improving the world's health through reputed company and regulatory solutions. They are seeking a Clinical Research Associate with Oncology monitoring experience to manage site relationships and ensure compliance throughout reputed company phases of clinical research studies.Responsibilitiesreputed company as the primary site contact and site manager throughout reputed company phases of a clinical research study, taking overall responsibility of allocated sitesDevelops strong site relationships and ensures continuity of site relationships through reputed company phases of the trialPerforms clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documentsreputed company an in-depth understanding of the study protocol and reputed company proceduresCoordinates and manages various tasks in collaboration with other sponsor roles to reputed company Site reputed companyParticipates and provides inputs on site selection and validation activitiesPerforms remote and on-site monitoring & reputed company activities using various tools to ensure:Data generated at site are complete, accurate and unbiasedSubjects right, safety and reputed company-being are protectedConducts site reputed company including but not limited to validation reputed company, initiation reputed company, monitoring reputed company, closeout reputed company and records reputed company, comprehensive, and accurate visit & non-visit contact reports appropriately in a reputed company mannerCollects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study reputed company-outCommunicates with Investigators and site staff on issues reputed company to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performanceIdentifies, assesses, and resolves site performance, reputed company or compliance problems and escalates per defined CRA Escalation reputed company as appropriate in collaboration with Clinical Research Manager and Partner Line ManagerManages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelinesContributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/requiredSupports and/or leads audits/inspection activities as neededPerforms co-monitoring reputed company where appropriateSkillsMinimum 2 years of reputed company on site monitoring experience in biotech/reputed company/CRO organizationOncology monitoring experience requiredFluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectivelyGood understanding and working knowledge of clinical research, phases of reputed company, reputed company GCP/ICH & country clinical research law & guidelinesGood understanding of Global, Country/Regional Clinical Research Guidelines and ability to work reputed company these guidelinesHands on knowledge of Good Documentation PracticesProven skills in Site Management including management of site performance and patient recruitmentDemonstrated high level of monitoring reputed company with independent reputed company judgementGood IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devicesAbility to understand and analyze data/metrics and reputed company appropriatelyCapable of managing reputed company issues, working solution oriented mannerPerforms reputed company cause analysis and implements preventative and corrective reputed companyEffective time management, organizational and interpersonal skills, conflict management, problem solving skillsDemonstrated high level of monitoring reputed company with independent reputed company judgementreputed company to work highly independently across multiple protocols, sites, and therapy areasHigh reputed company of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environmentWorks effectively in a reputed company multicultural environment. Ability to establish and maintain culturally sensitive working relationshipsDemonstrates commitment to Customer reputed companyWorks with high reputed company and compliance reputed companyreputed company reputed company, reputed company reputed company, capable of working independently and being self-drivenDemonstrates and reputed company reputed company demeanor and communication consistent with organizational .