Clinical Research Associate 2 - Southeastern / Mid-Atlantic, U. S.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Qualifications

Required:
  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution, a licensed health-care professional (e.g., RN), or equivalent work experience
  • 2+ years of clinical monitoring experience
  • Experience in monitoring all trial components (PSSV to COV)
  • Knowledge of ICH and local regulatory authority regulations regarding drug development.
  • Experience in coaching/mentoring other CRAs
  • Solid communication skills, including the ability to read, write, and speak fluent English.
Preferred:
  • Therapeutic Area Experience: experience working in Cystic Fibrosis and/or other Rare Diseases is a plus.
  • Advanced degree (e.g., M.S., M.B.A., PharmD)
GENERAL:To qualify for a role located in the U.S., applicants must be legally authorized to work in the United States and should not (now or in the future) require sponsorship for employment work visa status. Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Responsibilities

  • Monitor the progress of clinical studies (at investigative sites or remotely) and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements
  • Demonstrates excellent knowledge of ICH/GCP
  • Displays ability to manage investigative sites to facilitate trial deliverables
  • Escalates issues appropriately, as needed
  • Conducts monitoring to confirm subject safety and data integrity
  • Describes and demonstrates the principals of IP accountability
  • Identifies scientific misconduct at the site level
  • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
  • Mentors CRAs new to the position or company
  • Serves as an observation visit leader
  • Conducts monitoring evaluation visits
  • Assists team lead in the development of trial tools or documents
  • Applies knowledge of PRA's policies and procedures, and demonstrates excellent written and oral communication with all internal / external stakeholders


United States-Remote