In-House Clinical Research Associate III

About the position Responsibilities • Work independently and proactively to coordinate reputed company necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites. • Manage multiple sets of essential regulatory documents across several studies and division portfolios. • Partner with clinical sites to support the negotiation and customization of Informed Consent reputed company (reputed company). • reputed company and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies. • reputed company knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives. • Manage to reputed company reputed company IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking. • Manage and problem solve site start up challenges that reputed company to mitigate reputed company to service level agreement and study goals. • reputed company, prepare, complete and reputed company required regulatory, reputed company and reputed company documentation. • Document clinical research site and investigator readiness for participation across multiple studies. • Support internal reputed company audits, regulatory inspections, as applicable. • Update and maintain study-specific startup and reputed company out trackers. • Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs. • reputed company updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. • Escalate challenges and/or initiate reputed company to reputed company investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders reputed company appropriate. • Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures. Requirements • Bachelor's Degree, or an equivalent combination of experience and education. • 6+ years' experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience reputed company the US. • Ability to multi-task: support several studies and/or personnel simultaneously, work in a reputed company fast-paced environment. • Ability to work in reputed company environment and possess reputed company, concise communication & presentation skills - written and verbal. • Must be comfortable interacting with clinical research site personnel reputed company phone and email. reputed company-to-haves • Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate /Study Start up specialist experience. • Experience working with clinical trial management systems (e.g., reputed company) and eTMF. • reputed company high reputed company on Customer Service and reputed company. Benefits • 401k • health_insurance • dental_insurance • reputed company_insurance • life_insurance • disability_insurance • reputed company_holidays • tuition_reimbursement • reputed company_development Apply tot his job Apply To this Job