Ref #: 30597

Employment type: Permanent - Full-Time

Location: Poland

Posted: 09-Jul-2021

Description

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.

Overview

CRA II/ Snr CRA conducts clinical site monitoring visits across multiple protocols and multiple therapeutic areas, ensuring studies arc conducted according to all applicable regulations and business processes.

Responsibilities:
?Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), !CH Guidelines, and Client Standard Operating Procedures (SOPs) and business processes.
?Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives.
This includes but is not limited to:
•Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues.
•Prepare local versions of ICFs
•Prepare of Regulatory and EC submission packages
•Identify, evaluate and recommend new/potential investigators/sites on an on-going basis.
•Management of payment for sites
•Ensure quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
•Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
•Appropriately escalate serious or outstanding issues to Clinical Operations Manager (COM) or the appropriate project team member(s).
•Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.

Requirements:
•At least Bachelor degree
•Minimum of 1 years of clinical related experience
•Strong site management and monitoring skills
•Excellent communication skills

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 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 through the form below.

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