In-House CRA l

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.

• General Summary:

   

  This position is open for Level 1 or Level 2 candidates.  The In House Clinical Research Associate (IHCRA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.  At the Senior level, the IHCRA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.

   

   

  Responsibilities Include:

   

  • Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites. 
  • Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked.
  • Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
  • Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
  • Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
  • Documents site and Sponsor contact and study interactions in a timely and professional manner.
  • Assists with resolution of investigational site/data queries.
  • Liaises with project team members regarding study site issues.
  • Provides quality review of the informed consent template.
  • Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.
  • Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments.
  • Performs other duties as assigned.
  • For Level 2, in addition to the above:
  • Liaises with internal and external customers to meet project specific goals including participation in sponsor and project related meetings
  • Acts as a liaison with clinical supply/service vendors and other functional area team members to meet project team goals.
  • Identifies, monitors, documents, and tracks out-of-scope activities.
  • Supports Clinical Team Manager (CTM)/Start Up Lead (SUL) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.
  • Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query distribution to/from investigational sites.
  • Proficient in the development and review of Informed Consent Form templates.
  • May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents.
  • Assists in the creation and maintenance of clinical project documents including, but not limited to Clinical Management Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans under the guidance of the SUL/CTM.
  • Supports the CTM/SUL/CRA to resolve internal and external clinical issues for client research projects managed by ICON.
  • Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions.
  • Supports CTM/SUL/CRA in the management of clinical budget and evaluation of study processes.
  • Evaluates metric data to identify process improvements.
  • Assists with managing and training staff.
  • Manages time and project requirements based on study contract.
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Qualifications:

• Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional
• 0 – 2 years of related experience for Level 1; 2+ years of related experience for Level 2
• Prior experience using computerized information systems.
• Clinical trials support or pharmaceutical industry experience preferred.
• Experience with PC-Windows, word processing, and electronic spreadsheets preferred.
• Office based or clinical employment experience preferred.
• Knowledge of ICH and local regulatory authority drug research and development regulations preferred.

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.