Study Start Up Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Study Start Up 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

Responsibilities

Responsible for supporting the Site Relationship Partners and investigator for Targeted Sites:

Clinical Trial Site Activation & Conduct

• Assist with study site activation activities to ensure timely site activation.
• 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.
• Support local IRB workflow from submission through approval and support reporting of updates to safety information.
• 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 such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines.
• Communicate site approvals to the Site Relationship Partners, Study Start Up Project Managers (where applicable) and relevant study team members.
• 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 such as documents for protocol amendments and FDA 1572 revisions.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
• Problem solve identified issues with appropriate timely escalation to the Site Relationship Partner.
• Assist the Site Relationship Partner with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Support investigator sites, Site Relationship Partners, Study Managers and study teams in preparation for and providing responses to site audits/inspections.

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.
• Respond promptly to GSSO team member and investigator site requests.
• Establish tools for efficient updates to the GSSO Study Team members as needed regarding site status, issues, delays, and approvals.

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.
• 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.
• In support of Site Relationship Partner, 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.
• Identify and resolve in collaboration with Site Relationship Partner investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues.
• Assist to resolve data queries within required timelines; support database release as needed for supported sites/functions.

You are:

Minimum 2 years of 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

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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. 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, colour, 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.