Regulatory Affairs, Study Start Up Specialist
Company: CTI Clinical Trial Services, Inc
Posted on: June 6, 2021
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
- Compile site Regulatory binders according to CTI SOPs or
sponsor PSOPs, perform a QC review of binders and ship binders to
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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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