Senior Regulatory Affairs, Study Start Up Specialist
Location
Rio de Janeiro, RJ | Brazil
Job description
Senior Regulatory Affairs, Study Start Up Specialist
Essential Functions:
- 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 to each country and site requirements
- Perform 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, 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
- Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level
- Assist in preparation, quality check, and filing of site adapted ICF according to local requirements
- Prepare 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 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
- Assist with preparation for Sponsor or Agency audits and inspections
- Assist with 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
- Sites budgets and Sites contracts management, depending on Countries/Regions
Required Education/Experience:
- Associate or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
- At least of 3 years of relevant pharmaceutical, site, or CRO Regulatory experience
- Experience in Clinical Trials Submissions in several LATAM countries
- Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) regulations and guidelines.
- Ability to work well in a team environment
- Ongoing willingness to learn
- Detail oriented
- Excellent verbal and written communication skills
- Fluent in oral and written English is a must, good Spanish language skills are also needed
- Ability to develop, prioritize, organize, and manage multiple tasks
- Ability to provide superior level of customer service
- Proficient in use of computer and software systems
- Ability to maintain confidentiality
- Strong understanding and application of principles, concepts, practices, and standards of CRO industry.
Why CTI?
- We support career progression – We have a structured mentoring program to provide the support you need to move forward
- We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
- Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (arecent report found that the average turnover for CROs in the US was 30%)
- Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
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