Job Description
Job DescriptionPrimary Job Title:
Clinical Study AdministratorAlternate/Related Job Titles:
- Clinical Trial Administrator
- Clinical Research Coordinator
- Clinical Study Specialist
- Clinical Trial Assistant
- Clinical Operations Coordinator
Location:
Wilmington, DEOnsite 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:
26-02570Hashtags:
#gttic #gttjobsCompany DescriptionGlobal Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.
We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.
There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: https://bit.ly/gttcareers
Awards
SIA’s Fastest Growing Staffing Firm: 2023 and 2015
SIA’s Best Staffing Firm to Work for: 2019 -2023
Inc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015
Randstad Preferred Supplier: 2020 - 2023
TechServe Alliance Excellence Award. 2019
NH Business Magazines Fast 5 fastest growing companies
Ernst & Young Entrepreneur of the Year Finalist: 2015
Company Description
Global Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.\r\n\r\nWe are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.\r\n \r\nThere is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: https://bit.ly/gttcareers \r\n \r\nAwards\r\n\r\nSIA’s Fastest Growing Staffing Firm: 2023 and 2015\r\nSIA’s Best Staffing Firm to Work for: 2019 -2023\r\nInc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015\r\nRandstad Preferred Supplier: 2020 - 2023\r\nTechServe Alliance Excellence Award. 2019\r\nNH Business Magazines Fast 5 fastest growing companies\r\nErnst & Young Entrepreneur of the Year Finalist: 2015