SMA II

As a SMA II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• The  In-House CRA 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. 

   

  Responsibilities:

  • 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.** LEVEL 2 RESPONSIBILITIES ALSO INCLUDE:
  • 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 Plansunder 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.

You are:

• Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional
• Prior experience using computerized information systems.
• Minimum of 2 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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.