Senior CRA

As a Sr. 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.
▪ 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.
▪ Provide initial and ongoing training to clinical investigators and other site staff regarding the study
protocol, procedures, documentation, as well as regulatory requirements.
▪ Perform Interim Monitoring Visits for assigned studies

▪ Perform Close Out visits as assigned.
▪ 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
▪ May assist in the preparation and follow-up of on-site Client sponsored quality audits and regulatory
authority inspections as assigned.

You are:

▪ BA/BS, or equivalent, or a minimum of 4 years of 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.
o 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.
o 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.

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.