Government Sector Sr. In-House CRA

Emmes • Rockville, WA

1d • 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 be referred to as a Clinical Trial Associate on some contracts.

Working under the high-level supervision of project site management staff, such as a Clinical Trial Manager, Lead CRA, or Clinical Project Manager, this role uses knowledge of study protocols, monitoring plans, and study manuals to respond to site needs. It also maintains essential study documentation, supports site communications and regulatory submissions, tracks trial progress, and may assist with monitoring visits, audit preparation, data review, and site training.

Emmes Group describes its work as bringing people, science, and technology together to advance global health. The company offers a competitive benefits package and opportunities to participate in community engagement through its Emmes Cares program. The position is listed as remote, with work from anywhere in the United States.

Requirements

• Bachelor’s degree; a scientific discipline is preferred, or directly applicable work experience may be considered.
• 2–3 years of relevant clinical research experience, such as experience as a CTA, in-house CRA, or study coordinator.
• 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 communication and interpersonal skills.
• Demonstrated problem-solving skills, self-motivation, and adaptability in a dynamic environment.
• Knowledge of prioritization, organization, critical thinking, decision-making, time management, and planning activities.
• Ability to collaborate with internal and external colleagues and work effectively in a team-oriented setting.

Responsibilities

• Use knowledge of study protocols, site monitoring plans, and study manuals to triage site staff questions and requests.
• Collect, review, maintain, and track essential documents, assessing them for completeness, accuracy, good documentation practices, and 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 a site.
• Update the Clinical Trial Management System and other software tools to track trial progress.
• Provide mentorship and training to junior project staff.
• Assist with audit preparation as needed.
• Assist CRAs with post-visit issue and action-item resolution and track action items to completion.
• Track site training and recruitment efforts, and collect and review site screening logs.
• Assist with database review to assess data currency and help site teams resolve data queries or discrepancies.
• Review site-specific informed consent language before submission to the IRB/EC.
• Prepare and conduct training and retraining of site staff.
• Prepare meeting agendas and minutes.
• Assist with preparation of study documents and ordering clinical trial supplies from vendors, as needed.
• Assist experienced CRAs with remote or on-site qualification/pre-study, site initiation, interim/routine monitoring, closeout, and for-cause visits, as needed.
• Perform remote review and monitoring of informed consent forms and other source documents, as needed.
• Assist with preparation of Data and Safety Monitoring Board (DSMB) meeting materials, as needed.
• 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 & Work Environment
• Opportunities for volunteerism through the Emmes Cares community engagement program
• Competitive benefits package focused on the health and needs of the workforce

What This Job Offers

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