Senior Regulatory Affairs, Study Start Up Specialist

About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused 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
What You'll Do
Assist/Advise project teams on all regulatory requirements for clinical studies
Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
Review and adapt study specific documents according each country and site requirements
Perform / oversee 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 each country requirements
Receive and process study documentation from sites, check content and quality as well as completeness
Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review
Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements and /or perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy
Preparation and/or quality check and filing of site adapted ICF according to local requirements
Prepare or/and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable
Interact with Sponsors as needed; forward 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 liaison 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)
Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
Perform review, reconciliation, close-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 related Regulatory documents and reports
Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
Represent the Regulatory Department in capabilities and bid defense presentations
Train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work
Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs
What You'll Bring
Associates or bachelor's degree in allied health field such as nursing, pharmacy, or health science or the equivalent relevant experience
A minimum of 5 - 8 years relevant pharmaceutical or CRO Regulatory experience
Experience in Clinical Trials Submissions in several Latam countries
Strong working knowledge and understading of FDA, Good Practice (GCP)/International Council for Harmonisation (ICH) regulations and guidelines
Competencies
Ongoing willingness to learn
Detail oriented
Ability to collaborate well in a team environment
Ability to maintain confidentiality
Proficient in use of computer and software systems
Excellent verbal and written communication skills
Fluent in oral and written English
Ability to provide superior level of customer service
Ability to develop, prioritize, organize, and manage multiple tasks
Strong decision making and creative problem-solving skills
Strong understanding and application of principles, concepts, practices, and standards of CRO industry
Strong working knowledge and understanding of national and international regulations and guidelines, Good Clinical Practice (GCP) and International Council for Harmonization (ICH)
Why CTI?
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