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About the position Responsibilities • Work independently and proactively to coordinate all 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 Form (ICF). • Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies. • Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives. • Manage to achieve target 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 arise to mitigate impact to service level agreement and study goals. • Develop, prepare, complete and track required regulatory, ICF and legal documentation. • Document clinical research site and investigator readiness for participation across multiple studies. • Support internal quality audits, regulatory inspections, as applicable. • Update and maintain study-specific startup and close out trackers. • Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs. • Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. • Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when 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 within the US. • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment. • Ability to work in a team environment and possess clear, concise communication & presentation skills - written and verbal. • Must be comfortable interacting with clinical research site personnel via phone and email. Nice-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., Veeva) and eTMF. • Very high focus on Customer Service and quality. Benefits • 401k • health_insurance • dental_insurance • vision_insurance • life_insurance • disability_insurance • paid_holidays • tuition_reimbursement • professional_development Apply tot his job