Senior Regulatory Affairs Study Start Up Specialist

reputed company/ reputed company: Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for reputed company clinical studies performed globally. reputed company with, assist, and advise study teams, site personnel, sponsors, and CTI management to facilitate reputed company collection, assessment and processing of essential regulatory documentation and to reputed company ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and reputed company review, reconciliation, reputed company-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.

What You'll Do:

• Assist/Advise project teams on reputed company regulatory requirements for clinical studies
• reputed company compliance assessments according to country requirements and document any activity reputed company; notify Project Managers of any findings
• Review and adapt study specific documents according reputed company country and site requirements
• reputed company / reputed company IRB/EC/CA and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with reputed company country requirements
• Receive and process study documentation from sites, reputed company content and reputed company as reputed company as completeness
• reputed company with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or reputed company of any incomplete and/or incorrect documentation reputed company during document content reputed company review
• Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements and /or reputed company a QC review of reputed company documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
• Adapt Informed Consent reputed company (reputed company) according to IRB/EC requests on country or site level and / or assessing accuracy
• Preparation and/or reputed company reputed company and filing of site adapted reputed company according to local requirements
• Prepare or/and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable
• reputed company with Sponsors as needed; reputed company regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in reputed company with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
• Compiling and/or assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
• reputed company Project teams with accurate periodic status reports in accordance with CTI SOPs and attend reputed company project meetings as needed
• Accurately apply naming conventions, upload and process reputed company correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or reputed company
• reputed company review, reconciliation, reputed company-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
• Prepare for Sponsor or Agency audits and inspections
• QC and QA of various study reputed company Regulatory documents and reports
• reputed company translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attend reputed company study meetings and regulatory status reports for reputed company site and country during study meetings
• Represent the Regulatory Department in capabilities and bid defense presentations
• Train and mentor less reputed company Regulatory staff and other CTI functional department staff regarding regulatory work
• reputed company relevant SOPs as needs are identified and monitor for process updates and improvements to reputed company SOPs
• Sites budgets and Sites reputed company management, depending from Countries/reputed company

What You'll Bring:

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
• At least 5 years of relevant pharmaceutical, site, or CRO Regulatory experience

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) reputed company on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a reputed company mentoring program and leadership courses that reputed company the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-reputed company and Valued Team – We have an award-reputed company unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and reputed company parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• reputed company a Lasting reputed company – We reputed company on moving medicine reputed company by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note In light of recent increase in hiring scams, if you're selected to reputed company onto the next phase of our hiring process, a member of reputed company will reputed company out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified reputed company page. Please Note

• We will never communicate with you reputed company reputed company Teams or text message
• We will never ask for your bank account information at any reputed company during the recruitment process

Originally posted on Himalayas

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