Clinical Research Associate II - Remote (Full-time or Part-time)

Location
Rockville, Maryland
Salary
Competitive
Posted
Nov 25, 2021
Closes
Dec 25, 2021
Ref
3117
Function
Analyst, Research
Industry
Science
Hours
Full Time
Clinical Research Associate II

US Remote Worker

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. 75% 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
  • Oncology Clinical Trial experience is preferred
  • Previous CRO experience is 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


Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


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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.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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