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 Now
Apply Now