Clinical Trial Associate - Study Start Up - Home based

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 skills:
  • Minimum of 1 years of related experience
  • Experience with PC-Windows, word processing, and electronic spreadsheets required.
  • Knowledge of ICH and local regulatory authority drug research and development regulations required.
  • Clinical trials support or pharmaceutical industry experience required.
Preferred Qualifications:
  • Bachelors or equivalent in a scientific or health care field preferred Bachelors or equivalent in a scientific or health care field preferred or equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
  • Minimum of 1-3 years of relevant experience required.
  • Experience in oncology clinical trials preferred.
  • Clinical operations experience at a small or mid-size company.
  • Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
  • Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
  • Excellent verbal and written communication skills.
  • Ability to collaborate and respond to changing circumstances and needs.
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

  • Supports all aspects of clinical trials during the study start-up phase
  • Ensures completeness and accuracy of CRO Site Contact Details Report and Clinical Site Status Reports and uploads them to the Site Activation and Enrollment folders on the Sharepoint Site on a weekly basis
  • Collaborates with CRO and CTM to ensure sites are moving through start-up in a timely manner and in accordance with projected site activation timelines; supports with any required escalation to sites or other functions within to mitigate risks and remove roadblocks
  • Reviews and assesses essential documents required for site activation and investigational product release
  • Perform periodic reviews of the CRO eTMF/TMF (eg. for essential documents required for IP release/site activation) to ensure adherence with standards and compliance with the relevant regulations and guidelines.
  • Reviews Site Selection Visit and Site Initiation Visit reports on an ongoing basis
  • Supports in the review of eCRFs, eCRF guidelines, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
  • Supports the planning of Investigator Meetings.
  • Additional activities may be assigned as appropriate.


United States-Remote