Clinical Research Coordinator II (Bothell Office)

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

Qualifications
  • Bachelor's degree preferred
  • Minimum of 2 years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
  • Experience in scientific discipline and multiple therapeutic areas preferred
  • Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance), HIPAA, Drug Development and Approval Process
  • Proficiency in MS Office including Word, Excel, and PowerPoint
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

Responsibilities
  • Entry of data into Clinical Trial Management Software (CTMS).
  • Generation of reports in CTMS.
  • Assist Clinical Research Associates with the following clinical study related activities including but not limited to:
  • Support Institutional Review Board submissions / document prep and correspondence (initial, amendments, renewals).
  • Support site / study training.
  • Assist in preparation of site training / study initiation materials.
  • Create and maintain study binders.
  • Contact and coordinate study participant recruitment and enrollment for internal trials, including:
  • Retain documentation necessary for this process.
  • Initiate, coordinate, and manage activities associated with external patient trials and focus group meetings, including locating participants, securing meeting locations, developing trial procedures, and designing survey materials.
  • Conduct quality audits through monitoring internally and externally (remotely or onsite) to ensure compliance with US or international regulations.
  • Maintain traceability and accountability of study devices.
  • Follow procedures to order study equipment.
  • Assist with device labeling, modified product process, set-up and shipments.
  • Manager return and disposition of study equipment.
  • Manager (generate and track) Purchase Orders (PO's) to facilitate study payments to sites and vendors.
  • Data Entry and Validation.
  • User Assessment Testing (UAT) of Electronic Data Capture (EDC) system develop Excel spreadsheets for data capture validate / audit per validation plan.
  • Initiate and track requests for legal agreements.
  • Support the timely and accurate compilation of: all study data, study reports, including SAP file / document entries.
  • Maintain professional relationships with internal associates.


United States-Washington-Seattle