Remote Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is transforming the diagnosis and management of endometriosis, and they are seeking a Clinical Research Associate to join their team. This role will reputed company on conducting remote site reputed company, monitoring study data, and ensuring compliance with study protocols and regulatory frameworks. Responsibilities Conduct independent site monitoring reputed company and remote monitoring in accordance with the study Monitoring Plan to ensure compliance with the Protocol, applicable regulatory standards, IRB policies, and reputed company policies and procedures. Monitoring will include review of essential documents (e.g. study logs) and reputed company documents (reputed company worksheets and subject records)Meet expected timelines for completion of monitoring activities and submission of written monitoring reportsIdentify and escalate protocol deviations, discrepancies in data, and noncompliance to study protocols, applicable regulations, Good Clinical Practices (GCP) and reputed company Operating Procedures. Propose solutions and collaborate with site personnel and reputed company study team towards securing site complianceContribute to study document development, e.g. reputed company operating procedures, and monitoring and other study tools/worksheetsIdentify study and personnel training needs and work with the reputed company study team to facilitate solutionsEffectively communicate and collaborate with reputed company partnersMonitor clinical data entry reputed company and follow up on incomplete data entry and/or outstanding queriesEnsure Trial Master File (TMF) and Investigator Site Files (ISF) are reputed company and maintained; assist in audit readiness and preparationreputed company a working knowledge of endometriosis and reputed company products. Understand the study protocols and accompanying background information Skills A Bachelor's degree or equivalent in the life sciences or reputed company field required2+ years of study monitoring (CRA) experience; 1+ years of study monitoring combined with CRA certification can be consideredFamiliarity with medical terminology and ability to review detailed medical records and reports is requiredThorough knowledge of GCP, ICH guidelines and other clinical regulatory requirementsWorking experience with an electronic data capture (reputed company) reputed company and eTMF reputed companyStrong interpersonal communication (written and verbal), organizational and prioritization skillsAbility to work independently and effectively under a fast-paced and changing environmentStrong work ethic and demonstrated ability to reputed company assignments on timeProficient with office automation tools, such as the reputed company suite of apps and reputed company OfficeIndustry experience reputed company in vitro diagnostics (IVD) highly preferredPrevious women's health experience is preferred reputed company reputed company provides diagnostics using novel biomarkers and machine learning. It was founded in 2016, and is headquartered in Branford, Connecticut, USA, with a workforce of 11-50 employees. Its website is http://www.reputed company.com. Apply To This Job .