Associate CRA

Location
Rockville, Maryland
Salary
Competitive
Posted
May 07, 2021
Closes
Jun 06, 2021
Ref
2856
Function
Other
Industry
Science
Hours
Full Time
Home-Based Associate Clinical Research Associate

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Clinical Research Associate will assist in monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. Travel is initially expected to 50-75% each month and may include international travel, dependent upon project assignment.

Responsibilities
  • Assists the CRA Service Group with meeting coordination, activities preparation, generation of meeting minutes and agendas
  • Assists in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation
  • Assist in coordination of study related payments, if applicable
  • Under the direction of the CRA Manager may contact and serve as the primary administrative point of contact for internal research staff, external vendors, as appropriate, and clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
  • Assist in the tracking and distribution of regulatory and safety reports
  • Assist project teams with trial progress tracking by updating the Emmes' Clinical Trial System, providing access to study/client systems (as appropriate)
  • Work in collaboration with internal and external colleagues to meet project objectives and timelines

Experience
  • Bachelor's degree, preferably in a scientific discipline or equivalent experience may be considered in lieu of degree
  • Prior clinical research coordinator experience preferred
  • Basic 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


CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - 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.

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