Site Management Associate

ICON plc•Blue Bell, SD

20h•Remote

About The Position

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.

Requirements

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 appl1cations 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 Stages without visa sponsorship

Responsibilities

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
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
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
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.
Organize meetings (create & track study memos/letters/protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Benefits

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.

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