Study Start Up Associate II

Descripción del puesto:

Study Start Up Associate II (Supporting North America region - US/CAN)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Study Start Up Associate II (Site Activation Partner) to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

In this role you will be 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 standards. Responsibility within a country and may span over more than one country depending on the geographical region and business needs.

What you will be doing

* 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
* 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
* Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
* Support investigators sites with local IRB workflow from preparation, submission through approval
* Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
* Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
* Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
* Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
* Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
* Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your profile
* Bachelor's degree in life sciences or a related field.
* Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
* Candidates must have very good level of English and experience working with US, as will provide support to NAM.
* Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
* Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

#LI-Remote

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:
* Competitive base salary and performance related incentives
* Health and wellbeing programmes including medical, dental, and vision coverage where applicable
* Retirement and pension plans
* Life assurance and disability coverage
* Employee assistance programmes and wellbeing resources
* Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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