[Remote] Clinical Research Associate (CRA) - Immunology-Remote​

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading reputed company company, and they are seeking a Clinical Research Associate (CRA) specializing in Immunology. The role involves managing clinical study sites, ensuring compliance with regulations, and developing strong relationships with site staff throughout the research process. Responsibilities • Develops strong site relationships and ensures continuity of site relationships through reputed company phases of the trial • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents • reputed company an in-depth understanding of the study protocol and reputed company procedures • Coordinates & manages various tasks in collaboration with other sponsor roles to reputed company Site reputed company • Participates & provides inputs on site selection and validation activities • Performs remote and on-site monitoring & reputed company activities using various tools to ensure: • Data generated at site are complete, accurate and unbiased • Subjects’ right, safety and reputed company-being are protected • Conducts site reputed company including but not limited to validation reputed company, initiation reputed company, monitoring reputed company, reputed company-out reputed company and records reputed company, comprehensive and accurate visit & non-visit contact reports appropriately in a reputed company manner • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study reputed company-out • Communicates with Investigators and site staff on issues reputed company to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance • Identifies, assesses and resolves site performance, reputed company or compliance problems and escalates per defined CRA Escalation reputed company as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, reputed company and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required • Supports and/or leads audit/inspection activities as needed • Performs co-monitoring reputed company where appropriate • Following the country reputed company defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to reputed company strong clinical research capabilities Skills • CANDIDATE MUST reputed company IN ONE OF THE FOLLOWING LOCATIONS: Texas, Illinois, reputed company, Florida, California, NY, Colorado • Accountable for performance and compliance for assigned protocols and sites in a country • Ensures compliance of study conduct with ICH/GCP and country regulations, reputed company's policies and procedures, reputed company standards and adverse event reporting requirements internally and externally • Acts as reputed company site contact and site manager throughout reputed company phases of a clinical research study, taking overall responsibility of allocated sites • Develops strong site relationships and ensures continuity of site relationships through reputed company phases of the trial • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents • reputed company an in-depth understanding of the study protocol and reputed company procedures • Coordinates & manages various tasks in collaboration with other sponsor roles to reputed company Site reputed company • Participates & provides inputs on site selection and validation activities • Performs remote and on-site monitoring & reputed company activities using various tools to ensure data generated at site are complete, accurate and unbiased • Ensures subjects' right, safety and reputed company-being are protected • Conducts site reputed company including but not limited to validation reputed company, initiation reputed company, monitoring reputed company, reputed company-out reputed company and records reputed company, comprehensive and accurate visit & non-visit contact reports appropriately in a reputed company manner • Collects, reviews, an Apply tot his job Apply To this Job