In-House Clinical Research Associate

Emmes Group•Rockville, MD

19h

About The Position

The In-House Clinical Research Associate (CRA), sometimes 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 that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and applicable regulatory requirements. The position works under the supervision of project site management staff, such as a Clinical Trial Manager, Lead CRA, or Clinical Project Manager. The In-House CRA supports study teams and site staff with essential-document collection and tracking, trial progress updates, communications, and a range of study coordination activities. Depending on project needs, the role may also contribute to audit preparation, site activation, recruitment tracking, study-document preparation, clinical-supply ordering, data-query resolution, and remote or on-site monitoring visits.

Requirements

Bachelor's degree in a scientific discipline is required.
Proficiency with the MS Office Suite.
Good computer and organizational skills.
High 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.
Proficient 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.
Knowledge of Good Clinical Practices and country regulatory requirements.

Nice To Haves

Previous clinical research experience of less than one year is preferred; examples include experience as a Clinical Trial Associate, in-house CRA, or study coordinator.

Responsibilities

Work under the supervision of project site management staff, such as a Clinical Trial Manager, Lead CRA, or Clinical Project Manager.
Use basic knowledge of the study protocol, site monitoring plan, and study manuals to triage site questions and requests, including enrollment updates, missing documentation, and meeting arrangements.
Collect, review, maintain, and track essential documents for completeness, accuracy, good documentation practices, and regulatory and local compliance.
Upload essential documents into the trial master file.
Communicate and coordinate effectively with internal project staff and site staff.
Update the Clinical Trial Management System and other software tools to help project teams track trial progress.
Assist with audit preparation activities as needed.
Assist the CRA with resolving post-visit issues and action items 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-query discrepancies.
Assist the site CRA in conducting remote and/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.