Study Start Up Associate

Descripción del puesto:

POL-SSUA-HB

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

Start Up Associate is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Sponsor's standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.

RESPONSIBILITIES

Clinical Trial Site Activation
*Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
*Register investigator sites and Sponsor stakeholders in Sponsor registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready.
*Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.
*Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.
*Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
*Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
*Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements.
*Coordinate the timely communication, documentation and responses between Sponsor and Central Ethics committee to bring clinical study to approval (country dependent).
*Support investigators sites with local IRB workflow from preparation, submission through approval.
*Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed.
*Collaborate with the Study Team on the development and readiness of sites eISF when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to SIV.
*Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Clinical Trials Conduct
*Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct.
*Ensure maintenance of IRB/Ethics and other committees' activities as applicable.
*Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.
*Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
*Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections.
Internal & External Communication
*Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
*Attend study Start-up meeting and provide functional updates on a country and site level.
*Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.
*Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable.
*Communicate Local sites approvals to study team members and stakeholders.

Clinical Trial Site Support
*As needed, perform, awareness session with site personnel on Sponsor requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Sponsor standards
*Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues

QUALIFICATIONS:
*School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor's degree in life sciences preferred
*Minimum 2 years relevant experience on the similar position in Pharma or CRO
*Experience working in the pharmaceutical industry/or CRO in study site activation is an must have.
*Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
*Must be fluent in Local language and in English. Multilanguage capability is an asset.
*Good technical skills and ability to learn and use multiple systems.
*Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details.
*Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach.
*Ability to work independently and also as a team member.

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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 maximize 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 site to read more about the benefits ICON offers.

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, 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 or submit a request here.

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.

Are you a current ICON Employee? Please click here to apply