Site Activation Specialist

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.

Summary of the role

The Site Activation Specialist is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned clinical trials.
Your will provide administrative support and collect documents for study submission and IP packages.

Responsibilities:
• Assist with study site activation activities to ensure timely site activation.
• Register investigator sites in registries as required.
• Work with investigator sites to complete critical information for site activation such as agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
• Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner.
• Prepare, validate and submit regulatory documents
• Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.
• Work with investigator sites throughout the study to complete required ongoing study documents.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports
• As needed, support with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and sponsors’ standards.
• In support of SSU Specialists conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities that facilitate inspection readiness.

• School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor’s degree in life sciences preferred. In general, candidates for this job would hold the following levels of education/experience:
• 2 years relevant experience in clinical site management
• Experience in study activation and site management is an asset
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Must be fluent in English, and the regulatory language of the appointed location

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.