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Regulatory Affairs, Study Start Up Specialist

Company: CTI Clinical Trial Services, Inc
Location: Covington
Posted on: June 6, 2021

Job Description:

Regulatory Affairs Study Start Up Specialist (level dependent on experience)
Job Purpose / Summary: Manage essential Regulatory documentation for multiple studies or projects. Interact with study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment, and processing of essential Regulatory documentation and to provide ongoing status reports about the documentation!

What You'll Do
  • Perform compliance assessments against Food and Drug Administration (FDA) lists and document any FDA activity discovered; notify Study Manager of any FDA activity documented per CTI SOPs.
  • Compile site Regulatory binders according to CTI SOPs or sponsor PSOPs, perform a QC review of binders and ship binders to sites.
  • Perform Central IRB submissions on behalf of sponsors and sites as agreed to in the scope.
  • Assist with informed consent form (ICF) modifications from sites per sponsor and site requirements for all types of consent forms used during each study (Assents, pharmacokinetics [PK], pharmacodynamics [PD], pharmacogenomics [PG], Parental, Health Insurance Portability and Accountability Act (HIPAA), etc.).
  • Receive and process study documentation from sites, assessing content quality for accuracy and completeness.
  • Interact with site personnel for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review.
  • Develop skills to accurately name, upload and process all correct and complete study documentation in the study startup module or tracker and study specific TMF system whether electronic or paper.
  • Provide Study Teams with accurate periodic status reports of documentation per CTI SOPs.
  • Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor PSOPs.
  • Assist with preparation for Sponsor or Agency audits and inspections.
  • Assist with QC and QA of various study related Regulatory documents and reports.
  • Accurately name, upload or file and process all content complete and correct documents in the TMF, whether electronic or paper, and apply the required metadata to result in correct auto filing of all electronic documents and/or manual filing of hard copies in paper files.
What You'll Bring
  • Associates or Bachelors Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
  • A minimum of 1 - 2 years of relevant pharmaceutical, site, or CRO Regulatory experience
  • Working knowledge and understanding of FDA, International Council on Harmonization (ICH) / Good Clinical Practice (GCP) regulations and guidelines
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 think globally and act locally We have a global philanthropic program supporting our teams 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 double-digit growth rate over the last decade, invest in cutting-edge 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 critically-ill patients, who are depending on us to bring these life-changing therapies to market!

Keywords: CTI Clinical Trial Services, Inc, Covington , Regulatory Affairs, Study Start Up Specialist, Other , Covington, Kentucky

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