In-House Clinical Research Associate

Emmes • Rockville, WA

1d

About The Position

The In-House Clinical Research Associate (CRA), also referred to as a Clinical Trial Associate on some contracts, assists with operational activities supporting site management and monitoring of clinical studies and trials. The role helps ensure clinical trials are conducted, recorded, and reported in accordance with study protocols, standard operating procedures (SOPs), and applicable regulatory requirements. Work is performed under the supervision of project site management staff, such as a Clinical Trial Manager, Lead CRA, or Clinical Project Manager. The role requires basic knowledge of study protocols, site monitoring plans, study manuals, Good Clinical Practices, and country regulatory requirements. The In-House CRA communicates and coordinates with project and site staff and supports study documentation, trial tracking, site activities, and monitoring.

Requirements

• Bachelor's degree in a scientific discipline.
• Proficiency with Microsoft Office Suite.
• Good computer and organizational skills.
• Strong attention to detail.
• Ability to work on varying projects and exercise critical thinking.
• Self-starter and team player able to work cross-functionally with heavy oversight.
• Proficiency in organizational, interpersonal, and oral and written communication skills.
• Demonstrated problem-solving skills; self-motivated and adaptable to 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

• Previous clinical research experience, such as as a Clinical Trial Associate, in-house CRA, or study coordinator.

Responsibilities

• Triage questions and requests from site staff, including enrollment updates, questions, missing documentation, and meeting arrangements, using knowledge of the protocol, site monitoring plan, and study manuals.
• Collect, review, maintain, and track essential documents, assessing completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
• Upload essential documents into the trial master file.
• Communicate and coordinate effectively with internal project staff and site staff.
• Support trial progress tracking by updating the Clinical Trial Management System and other software tools.
• Assist with audit preparation activities as needed.
• Assist the CRA with post-visit issue and action item resolution and track action items through completion.
• Track site training.
• Assist with feasibility and site activation processes in collaboration with clinical operations counterparts.
• Assist in preparing study documents.
• Assist with ordering clinical trial supplies from vendors, such as laboratories and investigational product depots.
• Track site 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.
• Assist the site CRA in conducting remote or on-site monitoring visits, including site initiation, interim routine monitoring, and closeout visits.
• Perform other duties as assigned.
• Comply with all policies and standards.

What This Job Offers

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