In House Clinical Research Associate (Site Management Associate) - Home-Based

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.

Overview:

• Responsible for supporting in-house CRA activities relating to the running of Clinical Trials as defined by the study budget.
• Providing support to the CRAs and directly to Sites to process and resolve queries and requests as required.

• Support the maintenance of Clinical Trial Master System (CTMS) and Trial Master File to ensure an inspection-ready state. Review for compliance and address findings as needed.
• Support CRA with resolution of follow up items, protocol deviations etc., by sending them CTMS reports and reminders periodically.
• Track site and study status as assigned.
• Collect and review site essential documents to support field CRA, as needed.
• Support requests from CRAs while they are onsite (vendor questions)
• Support site training documentation collection and tracking of training documentation
• Actively contribute to process improvement
• Undertake project related admin tasks e.g. meeting minutes, tracking, site document prep
• Actively contribute to site audit readiness through back-up activities with the primary site CRA. Including but not limited to; periodic eTMF review, collection of documents from the site, escalation of identified issues, CTMS up-to-date, etc. In-house CRA can be asked to assist in audit prep on-site as needed.
• May attend clinical trial site co-monitoring visits to support clinical trial admin activities such as ISF/eTMF reconciliation.
• Follow-up on outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites
• Work collaboratively and liaise with the CTA, LCRA and field CRAs
• Support CRA in ensuring all site supplies are available on site for site initiation visits and are in date for upcoming patient visits. Attends Investigator Meetings and study-specific training for assigned trials
• Assists with resolution of investigational site/data queries.
• Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked.
• Assists with Investigational Product accountability, subject screening/enrolment, Case Report form retrieval and query distribution to/from investigational sites.

• Bachelor's degree in life sciences discipline or relevant discipline preferred
• Typically requires 2 year of relevant work experience in the biopharmaceutical industry, or the equivalent combination of education and experience.
• Basic working knowledge of GCP, CFR and ICH guidelines and clinical trial operations
• Ability to work well with cross-functional Study Team and investigational sites
• Written, verbal and interpersonal skills to exchange straightforward information
• Demonstrates attention to detail
• Ability to work successfully under pressure with tight timelines
• Proficiency in Microsoft Office applications including Outlook, Excel, Word, and PowerPoint
• Demonstrates ability to identify issues and resolve them with guidance as needed

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.