Clinical Research Associate - Rare Disease (Full-time or Part-time)

Location
Rockville, Maryland
Salary
Competitive
Posted
Nov 06, 2021
Closes
Dec 05, 2021
Ref
3023
Function
Analyst, Research
Industry
Science
Hours
Full Time
Clinical Research Associate - Rare Disease

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 provide expert advice, guidance and general supervision to clinical monitoring team activities for designated rare disease projects and will monitor specified sites to ensure quality and integrity of data, compliance with standard operating procedures (SOPs), clinical monitoring plan, ICH GCP, regulatory requirements, ensuring study completion on time and within budget.

Responsibilities
  • Oversees site visits to determine protocol and regulatory compliance and prepares required documentation
  • Primary point of contact for the company in the global medical research community and develops collaborative relationships with investigative sites and client company personnel
  • Leads the execution of contracts and the progress of clinical projects
  • Ensures data entry by investigational sites is accurate and entered in a timely manner
  • Responsible for working with CRA managers to ensure quality, cost effectiveness, and timeliness of clinical trials
  • Liaises with other departments to revise/create and implement monitoring documents (monitoring checklists, templates, etc.)
  • Ensures that the professional activities of the department meet Federal Regulations (Title 21 CFR) and FDA guidelines, or corresponding country regulatory requirements
  • Coordinates investigator meetings, interacts with investigators, oversees project order changes, updates study guidelines, and completes quality control reports
  • May track clinical trial budgets, investigator payments, and coordination of studies
  • Mentors junior level Clinical Research Associates

Experience
  • Bachelor's degree in a scientific discipline or equivalent experience; combination of training and experience will be taken under consideration
  • Expertise monitoring rare disease trials required
  • Ability to travel domestically and internationally up to 75%
  • Minimum of 7 years of clinical research/monitoring experience
  • Strong understanding of regulatory obligations for a Clinical Research Associate and relevant ICH guidelines
  • Successful completion of ACRP CCRA or equivalent certification within one year of hire/transfer date
  • 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
  • Ability to work remotely with a high degree of independence
  • Skilled in data management/computer proficient in Microsoft Office


Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.

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.

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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