Sr. In-House CRA

Emmes Group; Rockville (MD); On-site; USD 65,000 - 90,000; Full time

Job summary

Emmes Group in Rockville, MD seeks a Senior In-House CRA to support site management and monitoring of clinical studies, ensuring trials are conducted and reported per protocol and SOPs. The role may involve program-level status tracking across multiple studies.

Ideal candidates will have solid knowledge of GCP and regulatory requirements, along with experience handling essential documents and study manuals, while maintaining regulatory compliance and quality across trials.

Qualifications

• Working knowledge of Good Clinical Practices (GCP) and country regulatory requirements.
• Familiarity with study protocol, site monitoring plan, and study manuals.
• Experience collecting, reviewing, and tracking essential documents.

Responsibilities

• Under the supervision of project site management, assist with site monitoring activities.
• Triage questions from site staff (enrollment updates, missing documentation, etc.).
• Maintain study documents and ensure accuracy and regulatory compliance.
• Support program-level status tracking and reporting across studies.

Skills

GCP knowledge

Regulatory knowledge

Study protocol familiarity

Job description

Be Part of One Team, One Purpose.

cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units -

Overview

Sr. In-House CRA

Be Part of One Team, One Purpose. At Emmes Group, we're shaping the future of clinical research - where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we've led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units - Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions - we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people - people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.

The Senior In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The Sr. In-House CRA may assist in program level status tracking and reporting across multiple studies. The Sr. In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

Responsibilities

• Under the high level supervision of the project site management staff oversight lead (i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.)
• Possesses working knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.).
• Has solid knowledge of Good Clinical Practices and country regulatory requirements.
• Independently collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local