Study Start Up Associate I

As a Site Activation Partner/ Study Start Up Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn't why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people's lives for the better every single day. It's who we are. And it's who you could be too. Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you'll be at the heart of our client's innovation.

What you will be doing:

Working fully embedded within the local clinical team at our client's offices, the Site Activation Partner is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring, and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and company standards. The Site Activation Partner will provide technical and logistical support to the Site Relationship Partners to deliver Investigator Initiation and Study Start Up. The tasks undertaken by a Site Activation Partner are varied and can include:

1. Clinical Trial Site Activation & Conduct
   • Assist with study site activation activities to ensure timely site activation.
   • Register investigator sites in company registries as required.
   • Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
   • Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
2. Communication
   • Act as a point contact for the GSSO team members for designated project site communications, correspondence, and associated documentation.
   • Maintain ongoing contact and communication with the GSSO team members as needed.
3. Clinical Trial Monitoring Support
   • As needed, support the Site Relationship Partner with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.
   • In collaboration with the Site Relationship Partner, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation.
   • In collaboration with Site Relationship Partner and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues.

You are:

• 2 years above IRB submission experience in clinical research field, USA & Canada
• 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
• Detail-oriented, passionate and reliable

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Company

Learn more about this company

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.