Clinical Trial Associate

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. 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 (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.
  
• 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 CMPs, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans under the guidance of the SUL/CTM.
  
• Supports investigators and investigative staff in fulfilling obligations regarding local submissions, according to the local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
  
• Assists with Investigational Product accountability, subject screening/enrollment, Case Report form retrieval and query distribution to/from investigational sites.
  
• Assists with resolution of investigational site/data queries; liaises with project team members regarding study site issues.
  
• Performs study tracking via the CTMS or a 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.
  
• Proficient in the development and review of Informed Consent Form templates; provides quality review of informed consent templates.
  
• 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 CTMS is accurately updated to allow the timely processing of Investigator Payments.
  
• 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.
  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 ICON 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.

Qualifications

• 2+ years of related experience in clinical trials support role and/or within the pharmaceutical industry.
  
• Experience with MS Windows / Outlook and other computerized information systems.
  
• Knowledge of ICH and local regulatory authority drug research and development regulations.
  
• Solid communication skills, including the ability to read, write, and speak fluent English.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

ICON is an EEO/AA employer and committed to providing opportunities to minorities, women, veterans and individuals with disabilities.OptionsApply for this job onlineApply Share Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Connect With Us!