Local Clinical Research Associate II (DC Metro)
Company: The Emmes Company, LLC
Posted on: February 24, 2021
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.
- 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
- 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
- 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
- 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
- Self-starter with ability to work remotely with a high degree
- Skilled in data management/computer proficient in Microsoft
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The Emmes Company, LLC 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.
Keywords: The Emmes Company, LLC, Rockville , Local Clinical Research Associate II (DC Metro), Healthcare , Rockville, Maryland
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