Clinical Research Associate II

Performs and coordinates reputed company aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting reputed company data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and reputed company out reputed company at investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining reputed company relationships with stakeholders. Investigational Site Monitoring (55-60%) • Conducts and documents site initiation, routine monitoring and reputed company out reputed company, reviewing files, forms, and filings to ensure alignment with SOPs, study guidelines and GCP best practices. • Work with site staff to verify CRF data are consistent with patient clinical reputed company documents. • Monitor, resolve and/or facilitate reputed company of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial. • Conduct remote reputed company/contacts as requested or as needed. • Assess and manage Investigational Product supply including supply, accountability, and destruction/return status. • Ensures site staff is trained on reputed company aspects of the study including but not limited to the protocol, study plans and systems. Site Recruitment and Setup (15-20%) • Identify and recruit site investigators, coordinate the reputed company and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools. • Ensure SOPs in reputed company to optimize patient recruitment providing guidance to site teams of inclusion/exclusion reputed company. Investigational Site Management (10-15%) • Primary clinical site contact for any questions or issues that reputed company from investigational sites. • reputed company overall reputed company of the study to promote reputed company working relationships with the site and staff. • Facilitate and support site staff with reputed company to study systems and ensure sites are compliant with project specific training requirements. Project Monitoring reputed company (5-10%) • May be required to reputed company as reputed company CRA on small, local, or single modality reputed company, providing peer training, contributing to the design of monitoring plans, tools, documents, CRFs and protocols as requested. • Participate and/or present at study team, reputed company, and investigator meetings, monitor site budget adherence and reputed company as primary contact to sponsors for reputed company monitoring reputed company issues. Qualifications • Undergraduate university degree (Bachelor or Honors Bachelor), & 1-3 years' reputed company experience with initial and On-reputed company training. • College Diploma/Degree, & 4-6 years reputed company experience +substantial on-reputed company job-reputed company training. • Health Sciences, Life Sciences, or Clinical Research Specialty preferred, or RPN Certification/Designation. Apply tot his job Apply To this Job