Clinical Trial Associate

Job Description

The Clinical Trial Associate (CTA) (Hybrid Germantown, MD) provides essential administrative and operational support to clinical trial sites and study teams. This role coordinates day‑to‑day study activities and ensures all trial documentation and logistics are managed in compliance with protocols, ICH‑GCP, regulations, SOPs, and study requirements.

• Lead the setup, organization, and maintenance of the TMF for assigned studies.
• Establish and manage electronic filing systems and Investigator Site Files (ISFs).
• Track ethics and regulatory submissions/approvals.
• Prepare, distribute, and archive essential trial documents.

• Assist CRAs with maintaining clinical systems that track site compliance and performance.
• Serve as a key contact for TMF and study material support.
• Coordinate investigator and study team meetings, including agendas, minutes, and follow‑up actions.

• Support site selection and study start‑up activities.
• Help develop study tools such as Operations Manuals and ISF/Pharmacy binders.
• Manage trial supplies (e.g., patient materials, lab kits, medical equipment).
• Maintain study databases, contact lists, and shared mailboxes.
• Assist with study newsletters and ongoing site communications.
• Process invoices, set up financial systems, and track investigator/vendor payments.
• Support Data Management by tracking and shipping CRFs and data queries.

• Assist in designing study logs and templates.
• Coordinate translations of study materials.
• Support CRAs during monitoring visits.
• Reorder clinical drug supplies as needed.
• Perform other tasks as assigned.

• Bachelor’s degree in a scientific discipline (or equivalent).
• 1+ year of relevant experience in a healthcare or pharmaceutical/biotech setting.
• Experience in clinical research preferred.
• Knowledge of ICH‑GCP and FDA regulations.
• Strong communication, organizational, and time‑management skills.
• High attention to detail and ability to work independently or in teams.
• Proficiency in Microsoft Office and ability to learn new systems.

With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health. We provide science-driven, independent testing, inspection, certification, and advisory services and develop the very standards that drive the food, water, and life sciences industries worldwide. We empower our clients to navigate shifting regulations to improve consumer health, safety, and quality of life.

One of our core values is We Are One NSF
. This means that while we’re one team, we embrace the cultural, ethnic, language, and demographic diversity that reflects the societies in which we live and work.

Come join a team that makes a difference in the world. More information about NSF can be found .

NSF is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.

From research to patient, NSF's expert team provides comprehensive regulatory, quality and clinical support to pharmaceutical, biotech, medical devices, in‑vitro diagnostics, and combination products clients across the product life cycle to navigate complex regulations and industry challenges.