Sign upLog in

Clinical Study Administrator

GTT

Wilmington, DE

Apply
JOB DETAILS
SKILLS
Administrative Procedures, Administrative Skills, Banking Services, Biology, Biotech and Pharmaceutical, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, Communication Systems, Contract Creation, Corporate Policies, Dental Insurance, Detail Oriented, Distribution Management, Document Management, Documentation, Documentation Format, English Language, Environmental Sciences, Financial Policies, Financial Services, Fortune 500 Customers, GCP (Good Clinical Practices), Healthcare, Healthcare Quality, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Logistics, Materials Tracking, Microsoft SharePoint, Multitasking, Organizational Skills, Payment Processing, Plan Meetings, Presentation/Verbal Skills, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Research Administration, Retail, Retirement Funds, Standard Operating Procedures (SOP), Startup, Team Player, Time Management, Training/Teaching, Vision Plan, Writing Skills
LOCATION
Wilmington, DE
POSTED
30+ days ago
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:
  • Medical, Vision, and Dental Insurance Plans
  • 401k Retirement Fund
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

About the Company

G

GTT