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Regulatory Affairs, Study Start Up Specialist

3 meses atrás

Rio de Janeiro, Rio de Janeiro, Brasil Mexico Tempo inteiro

ALL CV ́s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED

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
  • Perform review, reconciliation, closeout, 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.

Competencies:

  • 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

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 20year history, support a worklife 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 think globally and act locally
  • We have a global philanthropic program supporting our team's efforts to improve their local communities (click here to learn more about our "CTI Cares" program)
  • We are looking toward the future
  • We have had a consistent doubledigit growth rate over the last decade, invest in cuttingedge technology, and pride ourselves on our average 95% annual retention rate (a recent 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 criticallyill patients, who are depending on us to bring these lifechan