Senior CRA - English and Spanish Speaking

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

What you will be doing:

• Act as liaison between the in-house team, vendors, and multiple clinical sites.
• Work collaboratively with investigative sites to develop strong, long-term, working relationships.
• Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
• Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
• Assist with start-up activities, including essential document review and collection as requested.
• Perform Site Initiation Visits.
• Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
• Perform Interim Monitoring Visits for assigned studies:
• Monitor site compliance with study protocol, and GCP.
• Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.
• Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.

You are:

• BA/BS, or equivalent, or relevant experience and training with at least 6 years of pharmaceutical/biotech experience. RN or health care professional preferred.
• Prior monitoring experience is required. Oncology/hematology clinical trial experience is preferred.
• FDA/EMA inspection experience is preferred.
• Proficiency in CFR and GCP/ICH Guidelines is required. Experience working on global clinical trials is preferred.
• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).
• Excellent communication and organizational skills.

Why 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.

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.

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, colour, 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.

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.

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