Site Management Associate

Clinical Trial Coordinator (End to End) - Home Based (US)

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.

What you will be doing:

Trial and site administration:

• Tracking (e.g. essential documents) and reporting [e.g, Safety  Reports)

• Ensure collation and distribution  of study tools and documents

• Update clinical trial databases (CTMS) and trackers

• Clinical supply & non-clinical supply management, in Collaboration with other country roles

• Manage Labeling requirements and coordinate/sign translation change request

Document management:

• Prepare documents and correspondence

• Collate, distribute/ship, and archive clinical documents

• Assist with eTMF  reconciliation

• Updating  manuals/documents (e.g.,  patient diaries, instructions)

• Document proper destruction  of clinical supplies.

• Prepare Investigator trial file binders

• Execute eTMF Quality Control Plan

• Obtain  translations of documents

Regulatory & Site Start-Up responsibilities:

• In a timely manner, 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 regulatory agencies submissions.

• Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for

• Develop country and site budgets (including Split site budget)

• Tracking, and reporting of negotiations

• Maintenance of tracking tools

• Contract development, negotiation, approval and maintenance (e.g. CTRAs)

• Update and maintain contract; templates (in cooperation with Legal Department)

• Payment calculation  and execution (investigators,  vendors, grants)

• Ensure compliance with financial procedures

• Monitor and track adherence and disclosures,

• Budget closeout.

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)

• Support local investigator meetings (invitations, prepare materials, select venue, support vendor  where applicable)

What you need to have:

• B.A./B.S. (Life Science preferred) or equivalent healthcare experience

• Minimum 1-2 years in Clinical Research or relevant healthcare experience

• 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

• Effective time management, organizational and interpersonal skills, conflict management

• Effective communication with external customers (e.g. sites and investigators)

• High sense of accountability/ urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

• Demonstrates commitment to customer focus.

• Able to work independently

• Proactive attitude to solving problems/ proposing solution

• Eligible to work in the Unites States without visa sponsorship

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
• Empl