2 Regulatory Affairs Study Start Up Specialist (level dependent on experience) Jobs in Covington, KY
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CTI Clinical Trial and Consulting Services, Inc.
Covington, KY | Full Time
$75k-103k (estimate)
1 Week Ago
Regulatory Affairs Study Start Up Specialist (level dependent on experience)
$76k-103k (estimate)
Full Time
3 Days Ago
CTI is Hiring a Regulatory Affairs Study Start Up Specialist (level dependent on experience) Near Covington, KY
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 to each country and site requirements
- Perform IRB/EC (CA) 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/timelines 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 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
- Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
- Assist in responding to Contingency Letters from IRB/IEC/CA 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 ongoing maintenance of site documentation throughout the trial
- 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
- Associate's or Bachelor's degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
- A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience
- We support career progression - 25% of our global staff is promoted annually and 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 with flexible schedules, and have provided cash bonuses every year for the past decade
- Our culture is unparalleled - Click here to learn more about "The CTI Way"
- 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)
Job Summary
JOB TYPE
Full Time
SALARY
$76k-103k (estimate)
POST DATE
09/14/2024
EXPIRATION DATE
09/29/2024
WEBSITE
ctifacts.com
HEADQUARTERS
COVINGTON, KY
SIZE
500 - 1,000
FOUNDED
1999
TYPE
Private
CEO
TIMOTHY J SCHROEDER
REVENUE
$50M - $200M
INDUSTRY
Scientific Services
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About CTI
CTI is a contract research organization that offers clinical trial and consulting services to the pharmaceutical and biotechnology industries.
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