The Emmes Company, LLC is searching for a home-based Clinical Research Associate II, local to the DC Metro Area.

The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Clinical Research Associate is responsible for monitoring clinical study sites to ensure compliance with the clinical trial protocol, to check clinical site activities, to make on-site visits, to review Case Report Forms (CRFs) and to communicate with clinical research investigators. 25% travel monthly may be required.

Responsibilities

• Assists with the development and/or review of study-related materials including, protocols, informed consent forms, monitoring plan, monitoring documents, etc.
• Participates in the identification and recruitment of investigators and assists in the development of subject recruitment strategies and materials.
• Ensures that all visits are conducted according to FDA regulations and company standard operating procedures.
• Ensures adequate reporting/tracking of adverse events, protocol deviations, and subject status.
• Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to CRA Manager.
• Serves as point of contact for study site personnel to answer questions and resolve study-related issues.
• Ensures proper maintenance of required essential documents at the site level. Assists with set-up, maintenance, and reconciliation of Trial Master File.
• Prepares and attends project team meetings and provides updates on project status and site-specific performance.
• Works collaboratively and effectively in a project team environment.

Experience

• Bachelor's degree, preferably in a scientific discipline or equivalent experience may be considered in lieu of degree
• Minimum of 1-2 years of on-site monitoring experience required
• Previous CRO experience preferred
• Demonstrated understanding of regulatory obligations for a Clinical Research Associate and relevant ICH guidelines
• Skilled in prioritization, problem-solving, organization, critical thinking, decision-making, time management and planning activities
• Self-motivated and high attention detail required
• Ability to collaborate with internal and external colleagues and work well in team-oriented setting
• Excellent oral and written communication; exceptional interpersonal skills
• Self-starter with ability to work remotely with a high degree of independence
• Skilled in data management/computer proficient in Microsoft Office

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.