Government Sector Sr. In-House CRA

Emmes Group • Rockville, MD

2d • Remote

About The Position

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

The position works under the high-level supervision of project site management staff, such as a Clinical Trial Manager, Lead CRA, or Clinical Project Manager. It involves coordinating with site and internal project staff, maintaining essential documents and trial records, supporting site training and recruitment tracking, and assisting with monitoring, audit preparation, and study administration activities.

Requirements

• Bachelor's degree in a scientific discipline preferred, or directly applicable work experience; listed as required.
• 2–3 years of relevant clinical research experience, such as CTA, in-house CRA, or study coordinator experience.
• Proficiency with the MS Office Suite.
• Excellent computer and organizational skills.
• High attention to detail.
• Ability to work on varying projects and exercise critical thinking.
• Ability to work independently with limited oversight and collaborate cross-functionally as a team player.
• Knowledge of clinical research operations, including interpretation and implementation of country-specific regulations and ICH guidelines, as required.
• Excellent oral and written organizational, interpersonal, and communication skills.
• Problem-solving skills, self-motivation, and adaptability in a dynamic environment.
• Knowledge of prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities.
• Ability to collaborate with internal and external colleagues and work well in a team-oriented setting.

Nice To Haves

• Bachelor's degree in a scientific discipline.
• Directly applicable work experience.

Responsibilities

• Use knowledge of the study protocol, site monitoring plan, and study manuals to triage questions and requests from site staff.
• Collect, review, maintain, and track essential documents, assessing completeness, accuracy, good documentation practices, and compliance with regulatory and local requirements.
• Upload essential documents into the trial master file.
• Communicate and coordinate with internal project staff and site staff.
• Complete site IRB/EC submissions or submit to a central IRB/EC on behalf of the site.
• Update the Clinical Trial Management System and other software tools to provide trial progress tracking.
• Provide mentorship and training to junior project staff.
• Assist with audit preparation activities.
• Assist the CRA with post-visit issue and action-item resolution and track action items to completion.
• Track site training, recruitment efforts, and site screening logs.
• Assist with database review for data currency and support site teams in resolving data queries or discrepancies.
• Review site-specific informed consent form language before submission to the IRB/EC.
• Prepare and conduct training and retraining of site staff.
• Prepare meeting agendas and minutes.
• May assist in preparing study documents and ordering clinical trial supplies from vendors, including laboratories and investigational product depots.
• May assist an experienced CRA with remote or on-site monitoring visits, including qualification/pre-study, site initiation, interim/routine monitoring, closeout, and for-cause visits.
• May remotely review and monitor informed consent forms and other source documents.
• May assist with preparation of DSMB meeting materials.
• Perform other duties as assigned and comply with all policies and standards.

Benefits

• Flexible Approved Time Off
• Tuition reimbursement
• 401k retirement plan
• Work from home anywhere in the US
• Maternal/paternal leave
• Casual dress code and work environment
• Opportunities for volunteerism through the Emmes Cares community engagement program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior