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.

The Field CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines.

We are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams.

Principal Responsibilities:

• Act as liaison between the in-house team, vendors, and multiple clinical sites.
• Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits.
• Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials 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, Interim Monitoring Visits,Close Out visits as assigned.
• Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements.
• 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.
• Perform drug accountability and ensure adequate drug supply.
• Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required.
• Assist study team as necessary in resolving lab queries and other issues.
• Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.
• Ensure adequacy of clinical supplies to the site.
• Collect and review site essential documents and ensure site regulatory files are complete and accurate.
• Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals.
• Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance.
• Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
• Track, report, and follow all action items to resolution.
• Maintain CTMS in a timely fashion, utilizing available reports and study tools.
• Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP.
• Assist data management as required.
• Provide co-monitoring support as requested or as necessary to develop additional skills

You are:

Dedicated, collaborative and inspire others.

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• BA/BS, or equivalent, or a minimum of 1/2 years of other relevant experience and training. Prior oncology is preferred. Prior monitoring experience is required.
• Knowledge of and ability to apply CFR and GCP/ICH is required. Experience on global clinical trials is preferred.
• Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred). Previous experience with EDC and CTMS systems.
• Requires effective organizational and time management skills.
• Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail.
• Strong communication and interpersonal skills.
• Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals.
• Flexibility towards work assignments, learning, and travel.
• Able and willing to travel 60-80%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.
• Responsive and proactive, a team player.

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.