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_Job Summary_

Kedrion is seeking an experienced and driven **Senior Clinical Trial Assistant (CTA)** to join our Clinical Operations team on a contract basis. This role plays an essential part in supporting our clinical development programs, with a strong emphasis on **clinical trial document management, regulatory compliance, and Veeva Vault eTMF management and training** .

As a member of our Clinical Operations team, you will contribute to the successful execution of clinical trials from study start-up through close-out. You’ll be a central point of coordination for internal stakeholders, vendors, and study sites, ensuring trial activities are conducted efficiently and in accordance with GCP, ICH guidelines, and internal SOPs.

We are looking for a confident self-starter with deep experience managing eTMF documents and systems, particularly Veeva Vault, and a passion for training and supporting cross-functional teams in clinical operations best practices.

_Job Description_

Clinical Trial Support & Operational Oversight (Approx. 20%)

+ Support daily execution of clinical trials across various phases and therapeutic areas.

+ Coordinate administrative aspects of clinical studies, including scheduling internal and external meetings, supporting study start-up logistics, and managing documentation.

+ Assist with the preparation, review, and tracking of key trial materials such as Patient ID Cards, ICFs, newsletters, and regulatory documents.

+ Act as a liaison between clinical sites, vendors, and internal teams to ensure smooth communication and task follow-up.

+ Support clinical supply management, invoice tracking, and budget reconciliation.

+ Prepare and support monitoring visit activities and assist with study close-out processes, including archiving and document reconciliation.

Veeva Vault eTMF Management & Training (Approx. 70%)

+ Manage day-to-day eTMF operations, **including document upload** , review, QC, and reconciliation, ensuring alignment with the DIA reference model and regulatory expectations. (I moved this up and highlighted document upload as it is important the candidate is happy to do this)

+ Serve as the **primary point of contact and subject matter expert for Veeva Vault eTMF** , overseeing the maintenance, quality control, licenses, and audit-readiness of the Trial Master File. (Added the management of eTMF licenses here which is important when setting up study sites in the eTMF. They don’t have to have had experience but it will be included in the role)

+ **Train and guide internal and external personnel** on eTMF processes, expectations, and best practices; provide onboarding for new team members and ongoing training as needed.

+ Collaborate with Clinical Operations leadership to **develop eTMF SOPs, workflows, templates** , and training materials to drive consistency and compliance.

+ Proactively identify process improvement opportunities to enhance TMF quality, efficiency, and team understanding across studies and functional groups.

+ Conduct interim quality checks to ensure that TMFs are inspection-ready at all times.

Cross-Functional Support & Quality Oversight (Approx. 10%)

+ Support internal quality assurance initiatives such as spot-checking compliance documentation (e.g., CVs, training records).

+ Assist in tracking key regulatory and trial timelines (e.g., safety reporting deadlines, annual updates).

+ Support preparation for audits and inspections, including internal QA reviews and third-party reviews.

+ Assist with maintenance of quality system records and documentation in systems like TrackWise or MasterControl.

+ Help facilitate coordination with global teams during GCP audits and inspections.

_Requirements:_

+ You hold a Bachelor’s degree in Life Sciences, Healthcare, or a related field.

+ You have 3–5 years of hands-on experience in clinical trials, ideally in biotech/pharma environments.

+ You have **extensive experience managing and training others in Veeva Vault eTMF** , including document upload, QC, reconciliation, and compliance tracking. (I added document upload here)

+ You have a deep understanding of clinical trial operations, GCP, ICH guidelines, and essential regulatory documentation.

+ You’re familiar with tools like EDC, IRT, CTMS, and SharePoint, and comfortable using Smartsheet and Microsoft Project.

+ You bring excellent communication skills, both verbal and written, and enjoy coaching others in complex processes.

+ You’re detail-oriented, organized, and able to manage competing priorities in a fast-paced, collaborative environment.

+ You’re adaptable, a natural problem solver, and eager to grow within a team focused on continuous improvement.

+ You are located near Durham, NC, and willing to work on-site as needed.

_Additional Details_

+ **This is a contract position (6 months) with potential for conversion to full-time employment based on performance and business needs.**

+ Kedrion participates in E-Verify to confirm work authorization.

+ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Salary Range: $80-100k ($38.00-$48.07/hour – 40 hours per week)

_Please note that salary ranges are calcul_** **_ated based off levels of relevant experience, education and certifications._

_All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status._