Early Development Oncology CRA II
: Job Details :

Oncology Early Development

• 2 to 3 protocols
• 8 to 10 sites
• Sites will be local within driving distance or a short direct flight.
• Openings in North East - Must be located in the North East
• 50% Travel - 6 to 8 visits per month
• Hybrid of on-site and remote monitoring.
• No on-site metrics.
• Requirements: Must have a four-year degree, completed all visits independently and have two years of independent monitoring

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.

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.