Job Posting for Electronic Trial Master File (eTMF) Specialist at CTI Clinical Trial Services, Inc
Electronic Trial Master File (eTMF) Specialist
Job Purpose:
Independently oversee trial documentation management, quality oversight and inspection/audit readiness activities for the eTMF across multiple clinical trials according to CTI or Sponsor Global Standard Operating Procedures (GSOPs).
What You'll Do:
Oversee and guide eTMF processes and specific timelines assessments for each trial; monitor against trial progress and ensure trial activity is in compliance with relevant processes; suggest and implement alternative solutions for issues identified and take corrective action where necessary
Oversee receipt and processing of essential trial documentation including review of content, quality, and completeness
Ensure eTMF compliance and continual inspection readiness
Interact with Regulatory Affairs Study Start-up (RASSU), Clinical Project Assistants / Clinical Project Coordinators (CPAs / CPCs), Clinical Research Associates (CRAs), Clinical Project Managers (CPMs), eTMF Management, and other CTI functions for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation found during content quality review
Participation in internal, Sponsor, and regulatory authority audits and assist in responding to observations
Organize review / regular assessment of eTMF regarding correct naming, filing, as well as completion of essential documents
Ensure eTMF compliance with the achievement of established TMF timelines, milestones and appropriate trial maintenance requirements at all stages of trial conduct are met
Collaborate with eTMF Manager to organize administrative support in case of critical timelines on specific projects
Provide trial teams and/or Sponsor with accurate periodic status reports in accordance with CTI GSOPs and attend internal and external trial meetings as needed
Conduct / oversee QC of various trial-related essential documents and reports
Assist with maintenance and QC of various trial-related essential document trackers and reports
Access QC findings and document processing rejections, and educate trial teams and document processors regarding any identified patterns or errors in trial document quality and filing
Collaborate with Document Processing Management and provide input into potential system enhancements, updates, and reporting needs
Perform document quality review, reconciliation, close-out, shipment, and archiving activities of essential documentation according to CTI GSOPs and/or Sponsor SOPs
Forward and/or ship essential documentation to Sponsor in accordance with CTI or Sponsor SOPs
What You'll Bring:
Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
Minimum of 2-4 years pharmaceutical or CRO Clinical Regulatory and/or document / TMF management experience
Why CTI?
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it:
We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
We value education and training – We provide tuition assistance, 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 three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
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 – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
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 annual retention rate of 95%, which is much higher than many other CROs
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
Salary.com Estimation for Electronic Trial Master File (eTMF) Specialist in Hybrid remote in Covington, KY
$122,123 to $160,810
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