Site Management Associate I

As a Site Management Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are looking for candidates with previous experience in clinical trials, ideally as a CTA to join our FSP team and work as a sponsor dedicated Site Management Associate . This is a hybrid role.

In this role you will play a key role in successful local study delivery, providing subject matter expertise across key processes and systems through the live cycle of the study in Romania.

As the Site Management Associate you will work in collaboration with the Loccal Study Managers and CRAs to provide end to end operational and administrative support for study delivery activities in your assigned trials.

What you will be doing:

• Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with other teams
• Collate, distribute/ship, and archive clinical documents
• Assist with eTMF reconciliation
• Updating manuals/documents (e.g., patient diaries, instructions)
• Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatoryagencies submissions.
• Publish study results for GCTO and RA where required per local legislation
• Collaborate with finance/budgeting representatives for: country and site budgets  development, sontract development, negotiation, approval and maintenance (e.g. CTAs)
• Update and maintain contract templates (in cooperation with Legal Department)
• Payment calculation and execution (investigators, vendors, grants)
• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

• Graduate or Bachelor
• Minimum 1-2 years in Clinical Research or relevant healthcare experience
• A proven experience in clinical operations and/or global study management is required ( CTA, Global CTA, Project Associate)
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role

Why 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.

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.

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, 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.

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.

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