Clinical Trial Associate

NSF•Germantown, MD

14h•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a scientific discipline (or equivalent).
1+ year of relevant experience in a healthcare or pharmaceutical/biotech setting.
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.

Nice To Haves

Experience in clinical research preferred.

Responsibilities

Trial Master File (TMF) Management 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.
CRA & Study Team Support 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.
Study Operations 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.