Clinical Research Coordinator II - Remote, Minnesota

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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
  • Works with internal and external team members to deliver high quality trial execution
  • Performs study tracking (eg, CTMS, start-up, milestone, closeout); generates, reviews, and distributes management reports from internal tracking systems at requested intervals
  • Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes
  • Presents at team meetings as needed (ie, Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc)
  • Collects and reviews essential documents from investigational sites
  • Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
  • Participates in study-specific tasks such as investigator identification, recruitment, collection of regulatory documents, and site activation
  • Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
  • Assists in development of study materials, case report forms (CRFs), and informed consent documents for clinical studies
  • Prepares investigational site reference materials (ie, screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc)
  • Acts as primary contact for study contractors (eg, contract CTMs, field CRAs)
  • Keeps the Clinical Project Lead (CPL) informed of the progress of projects
  • Develops and maintains good working relationships with Investigators and study staff
  • Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
  • Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements, contracts, proposals, invoices, and other study documentation
  • Executes meeting logistics (eg, schedule meetings, distribute meeting agendas and minutes), as needed
  • May assist with study entry and updates to ClinicalTrials.gov
  • Assists with design and preparation of study related materials for the training of internal and external staff
  • Participates in co-monitoring activities and oversight of CRO or contract field CRAs for pre-study, initiation, routine monitoring and closeout visits
  • Assists with oversight of study vendors
  • Helps facilitate resolution of data queries and requests from Clinical Data Management
  • Assists with the tracking and management of study-specific budgets
  • Participates in development of departmental processes, SOPs, and initiatives


United States-Minnesota