Primary Job Title:
Clinical Study Administrator
Alternate/Related Job Titles:
Clinical Trial Administrator
Clinical Research Coordinator
Clinical Study Specialist
Clinical Trial Assistant
Clinical Operations Coordinator
Location:
Wilmington, DE
Onsite Flexibility:
Hybrid (3 Days Onsite; First 30 Days Fully Onsite)
Contract Details (Contract roles only):
Position Type: Contract
Contract Duration: 12 Months
Start: As Soon As Possible
Shift / Hours: 9 AM – 3 PM core hours (8-hour workday with 30-minute break; start time between 7 AM and 9 AM)
Job Summary:
The Clinical Study Administrator supports the coordination and administration of clinical study activities from study start-up through execution and close-out. Working closely with the Local Study Team (LST), this role ensures that clinical trial deliverables are completed according to quality, timeline, and regulatory requirements.
This position serves as a key administrative contact for investigators, clinical research associates, and external partners while maintaining study documentation, electronic trial master files (eTMF), and regulatory documentation to ensure inspection readiness and compliance with ICH-GCP guidelines.
Key Responsibilities:
Assist in the coordination and administration of clinical studies from start-up through execution and close-out
Collect, prepare, review, and track study documentation for submission to EC/IRB and regulatory authorities
Interface with investigators, CRAs, and external service providers during document collection processes
Serve as the local administrative contact and collaborate with CRAs and LSAD throughout the study lifecycle
Maintain and manage the local eTMF and Investigator Site File (ISF) according to regulatory and company requirements
Ensure essential study documents are uploaded and maintained to support inspection readiness
Support final archiving and completion of the local portion of the eTMF and assist with study close-out activities
Contribute to the preparation and maintenance of study documentation ensuring template and version compliance
Import and manage clinical regulatory documentation within global electronic document management systems
Support electronic submissions and regulatory documentation standards for regulatory authority submissions
Maintain information within study tracking and communication systems such as CTMS and SharePoint
Assist with site-level contract preparation where applicable
Support HCO/HCP payment processing in compliance with local regulations
Coordinate and track study materials and equipment
Assist with audits, inspections, and administrative study processes according to company policies and SOPs
Coordinate logistics and documentation for study team meetings, investigator meetings, and monitor meetings
Required Experience:
2–3 years of administrative experience
Experience supporting documentation and coordination activities within structured operational environments
Computer proficiency and experience managing electronic documentation systems
Nice-to-Have Experience:
Administrative experience in clinical research, healthcare, or life sciences environments
Understanding of the Clinical Study Process and working procedures
Familiarity with ICH-GCP guidelines and regulatory documentation processes
Experience supporting regulatory submissions or clinical trial documentation
Required Skills:
Clinical Study Coordination
Document Management and Tracking
Organizational and Administrative Skills
Preferred Skills:
eTMF / ISF Management
CTMS Systems (e.g., VCV, SharePoint)
Regulatory Documentation Preparation
Study Coordination and Logistics
Clinical Research Administration
Additional Skills:
Strong verbal and written English communication skills
Ability to work collaboratively in an international team environment
Ability to train others on study administration procedures
Excellent organization, time management, and attention to detail
Ability to manage multiple tasks in high-volume environments with shifting priorities
Strong interpersonal skills and teamwork orientation
Ability to coordinate meetings and prepare presentation materials
Document formatting, translation support, and distribution management
Knowledge of compliance requirements and company policies related to finance, security, and safety
High integrity and adherence to ethical standards
Benefits:
About the Client:
Global pharmaceutical organization focused on advancing healthcare through innovative clinical research and development. The organization collaborates with international teams, investigators, and regulatory authorities to support high-quality clinical studies and deliver impactful therapies to patients worldwide.
About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.
Job Number:
26-02570
Hashtags:
#gttic #gttjobs