Remote Clinical Research Associate (CRA) - Vaccine/Infectious Disease (Remote)

Note: The job is a remote job and is open to candidates in USA. reputed company is a reputed company seeking a Clinical Research Associate to oversee performance and compliance for assigned clinical research protocols and sites. The role manages site relationships, conducts remote and on-site monitoring, ensures adherence to clinical research standards and regulations, supports study activities, and develops new research sites.ResponsibilitiesDevelops strong site relationships and ensures continuity of site relationships through all phases of the trialPerforms clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and reputed company documentsGains an in-depth understanding of the study protocol and related proceduresCoordinates & manages various tasks in collaboration with other sponsor roles to achieve Site ReadyParticipates & provides inputs on site selection and validation activitiesPerforms remote and on-site monitoring & oversight activities using various tools to ensure: + Data generated at site are complete, accurate and unbiased. + Subjects right, safety and well-being are protectedConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely mannerCollects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-outCommunicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performanceIdentifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as neededWorks in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sitesManages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelinesContributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/requiredSupports and/or leads audit/inspection activities as neededPerforms co-monitoring visits where appropriateFollowing the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilitiesSkills* Ability to travel domestically and internationally approximately 65%-75% of working time* Expected travelling ~2-3 days/week* Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively* Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines* Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines* Hands on knowledge of Good Documentation Practices* Proven Skills in Site Management including management of site performance and patient recruitment* Demonstrated high level of monitoring skill with independent professional judgment* Good 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 devices* Ability to understand and analyze data/metrics and act appropriately* Capable of managing complex issues, works in a solution-oriented manner* Performs root cause analysis and implements preventative and corrective action* Effective time management, organizational and interpersonal skills, conflict management, problem solving skills* Demonstrated high level of monitoring skill with independent professional judgement* Able to work highly independently across multiple protocols, sites and therapy areas* High sense of accountability / urgency. Ability to set priorities and reputed company multiple tasks simultaneously in a changing environment* Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships* Demonstrates commitment to Customer focus* Works with high quality and compliance mind-set* Positive mindset, growth mindset, capable of working independently and being self-driven* Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices* Associate's degree, certificate or equivalent in a scientific / healthcare discipline reputed company .