In-House Clinical Research Associate

Emmes Group•Rockville, MD

About The Position

The 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 In-House CRA may also be referred to as a Clinical Trial Associate on some contracts. 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.

Requirements

Bachelor's Degree Scientific discipline Required
Proficient with MS Office Suite High
Good computer and organizational skills High
High attention to detail required High
Ability to work on varying projects and exercise critical thinking High
self starter and a team player who can work cross functionally with heavy oversight High
Proficient in organizational, interpersonal, and communication skills both oral and written High
Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High
Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High
Ability to collaborate with internal and external colleagues and work well in a team oriented setting High

Nice To Haves

less than 1 year Previous clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.) Preferred

Responsibilities

Under the supervision of the project site management staff oversight lead i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.
Possesses basic 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.
Knowledge of Good Clinical Practices and country regulatory requirements.
Collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
Upload essential documents into the trial master file.
Communicates and coordinates effectively with internal project staff members and site staff.
Assists project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
May assist in audit preparation activities as needed.
May assist the CRA in Issue and Action Item AI resolution post visit and assists with tracking AIs to completion.
Tracks site training
May assist with feasibility and site activation processes in collaboration with clinical operations counterparts.
May assist in preparing study documents.
May assist with ordering clinical supplies from vendors such as laboratories and Investigational Product depots.
May track site recruitment efforts and collect review site screening logs.
May assist with the review of the database to assess data currency and may assist site teams with resolving data queries discrepancies.
May assist on site CRA in the conduct of remote and or on site monitoring visits such as site initiation visits, interim routine monitoring visits and closeout visits
Performs other duties as assigned
Complies with all policies and standards