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ICON Strategic Solutions CRA II - Early Development - Northeast in Helena, Montana

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.

Responsibilities:

• To plan, execute and support clinical site management activities

• To ensure the quality and integrity of the data collected in sponsored clinical trials in accordance with the approved protocol, SOPs, ICH/GCP and regulatory requirements.

• To support the needs of internal and external clients or stakeholders.

General Activities:

• Conduct clinical trial site visits including evaluation, initiation, monitoring and close out

• Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems

• Proactive site management including:

o Building and maintaining solid and professional relationships with site staff

o Facilitating subject enrolment incorporating recruitment strategies and action plans at site level

o Maintaining site audit/inspection readiness

o Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks

o Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan

o Responding to site queries and escalating issues in accordance with processes and timelines

o Conducting IP accountability and reconciliation

o Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)

o Maintenance of site study supplies

Operational Excellence:

• Contribute to sponsor goals

• Promote operational and scientific excellence

• Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.

Qualifications:

• BA/BS/BSc in the sciences or nursing equivalent

• A trained CRA with on-site monitoring experience

• Comprehensive knowledge and understanding of ICH-GCP

• Fluent oral (face to face and telephone) and written English language skills

• Able and willing to travel up to 60% of the time or as per local requirements

• Possession of a full driver’s license

• Able and willing to work from a designated and appropriate home office as per local requirements

• Willing to attend and contribute to team meetings (DOCS/Sponsor) including mandatory training (remote/off-site)

• Competent computer skills including working knowledge of common software packages

• Working knowledge of trial management databases and on-line systems

• Able to attend a 1 week face to face in-house training course as part of on-boarding training

• Able and willing to work on several protocols/therapy areas

• Experience in phase II and phase III trials (preferred)

• Working knowledge of Electronic Data Capture (preferred)

• Experience/working knowledge of the oncology disease area (preferred)

• Experience of Centralized/Risk Based/Targeted monitoring (preferred)

• Experience of working within a metric based environment (preferred)

• Act as an ambassador for Sponsor

Attributes

• Strong team approach

• Process driven

• Excellent attention to detail

• Highly developed time management and organizational skills

• Focused on meeting study deliverables/targets

• Flexible and willing to adapt to changing priorities/timelines

• Excellent interpersonal skills (influencing skills and relationship management)

• Strong oral (face to face/telephone), written and presentation skills

• Proficient problem solving skills

• Ability and willingness to accept and contribute to change management

• Open to feedback on performance and willing to provide professional feedback for others

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.

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