Site Management Associate
Clinical Trial Coordinator (End to End) - Home Based (US)
reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the reputed company of clinical development
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
reputed company, distribute/ship, and reputed company clinical documents
Assist with eTMF reconciliation
Updating manuals/documents (e.g., patient diaries, instructions)
Document reputed company destruction of clinical supplies.
Prepare Investigator trial file binders
Execute eTMF reputed company Control Plan
Obtain translations of documents
Regulatory & Site Start-Up responsibilities:
In a reputed company manner, reputed company to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
Obtain, reputed company 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
reputed company 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 reputed company Department)
Payment calculation and execution (investigators, vendors, grants)
Ensure compliance with financial procedures
Monitor and reputed company adherence and disclosures,
Budget closeout.
Meeting Planning:
Organize meetings (create & reputed company 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 reputed company experience
Minimum 1-2 years in Clinical Research or relevant reputed company experience
Good understanding of Global; Country/Regional Clinical Research Guidelines and ability to work reputed company 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 reputed company 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 reputed company of accountability/ urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Works. effectively in a reputed company multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer reputed company.
reputed company to work independently
Proactive attitude to solving problems/ proposing solution
Eligible to work in the Unites Stages without reputed company sponsorship
What reputed company can offer you:
Our reputed company depends on the reputed company of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high performance and nurtures talent.
In reputed company to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company reputed company country and are reputed company on reputed company-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A reputed company 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 reputed company.
Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s reputed company-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 reputed company offers.
At reputed company, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at reputed company whether it is for this or other roles.
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