Government Sector Sr. In-House CRA

Emmes Group•Rockville, MD

17d

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. The position works under high-level supervision of project site management leadership, such as a Clinical Trial Manager, Lead CRA, or Clinical Project Manager.

Requirements

Bachelor's degree; a scientific discipline is preferred, or directly applicable work experience is preferred.
Two to three 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 as a self-starter and collaborate cross-functionally as a team player with limited oversight.
Knowledge of clinical research operations, including interpretation and implementation of country-specific regulations and ICH guidelines.
Excellent organizational, interpersonal, and oral and written communication skills.
Demonstrated 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.
Ability to collaborate with internal and external colleagues and work effectively in a team-oriented setting.

Responsibilities

Maintain working knowledge of study protocols, site monitoring plans, and study manuals to triage questions and requests from site staff.
Apply knowledge of Good Clinical Practices and country-specific regulatory requirements.
Collect, review, maintain, and track essential documents, assessing completeness, accuracy, good documentation practices, and regulatory and local compliance.
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 project teams with trial progress tracking.
Mentor and train junior project staff.
Assist with audit preparation as needed.
Assist the CRA 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 and 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.
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 preparing Data and Safety Monitoring Board (DSMB) meeting materials.
Perform other duties as assigned.
Comply with all policies and standards.