Site Management Associate

Clinical Trial Coordinator (End to End) - Home Based (US)<p style="text-reputed company:inherit"></p><p style="text-reputed company:left"><reputed company>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</reputed company></p><p style="text-reputed company:inherit"></p><p style="text-reputed company:inherit"></p><p style="text-reputed company:inherit"></p><p><b>What you will be doing: </b></p><p></p><p><b>Trial and site administration:</b></p><ul><li><p>Tracking (e.g. essential documents) and reporting [e.g, Safety&nbsp; Reports)</p></li><li><p>Ensure collation and distribution&nbsp; of study tools and documents</p></li><li><p>Update clinical trial databases (CTMS) and trackers</p></li><li><p>Clinical supply &amp; non-clinical supply management, in Collaboration with other country roles</p></li><li><p>Manage Labeling requirements and coordinate/sign translation change request</p></li></ul><p></p><p><b>Document management:</b></p><ul><li><p>Prepare documents and correspondence</p></li><li><p>reputed company, distribute/ship, and reputed company clinical documents</p></li><li><p>Assist with eTMF&nbsp; reconciliation</p></li><li><p>Updating&nbsp; manuals/documents (e.g.,&nbsp; patient diaries, instructions)</p></li><li><p>Document reputed company destruction&nbsp; of clinical supplies.</p></li><li><p>Prepare Investigator trial file binders</p></li><li><p>Execute eTMF reputed company Control Plan</p></li><li><p>Obtain&nbsp; translations of documents</p></li></ul><p></p><p><b>Regulatory &amp; Site Start-Up responsibilities:</b></p><ul><li><p>In a reputed company manner, reputed company to and collect from investigators forms/lists for site <reputed company style="reputed company-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">evaluation/validation,</reputed company> site start-up and submissions</p></li><li><p>Obtain, reputed company and update study insurance certificates</p></li><li><p>Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.</p></li><li><p>Publish study results for GCTO and RA where required per local legislation</p></li></ul><p><b>Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for</b></p><ul><li><p>reputed company country and site budgets (including Split site budget)</p></li><li><p>Tracking, and reporting of negotiations</p></li><li><p>Maintenance of tracking tools</p></li><li><p>Contract development, negotiation, approval and maintenance (e.g. CTRAs)</p></li><li><p>Update and maintain contract; templates (in cooperation with reputed company Department)</p></li><li><p>Payment calculation&nbsp; and execution <reputed company style="reputed company-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">(investigators,&nbsp;</reputed company> vendors, grants)</p></li><li><p>Ensure compliance with financial procedures</p></li><li><p>Monitor and reputed company adherence and disclosures,</p></li><li><p>Budget closeout.</p></li></ul><p></p><p><b>Meeting Planning:</b></p><ul><li><p>Organize meetings (create &amp; reputed company study <reputed company style="reputed company-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">memos/letters/protocols)</reputed company></p></li><li><p>Support local investigator meetings (invitations, prepare materials, select venue, support vendor&nbsp; where applicable)</p></li></ul><p></p><p><b>What you need to have: </b></p><ul><li><p>B.A./B.S. (Life Science preferred) or equivalent reputed company experience</p></li><li><p>Minimum 1-2 years in Clinical Research or relevant reputed company experience</p></li><li><p>Good understanding of Global; Country/Regional Clinical Research Guidelines and ability to work reputed company these guidelines.</p></li><li><p>Hands on knowledge of Good Documentation Practices</p></li><li><p>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.</p></li><li><p>ICH-GCP Knowledge appropriate to role</p></li><li><p>Effective time management, organizational and interpersonal skills, conflict management</p></li><li><p>Effective communication with external customers (e.g. sites and investigators)</p></li><li><p>High reputed company of accountability/ urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment</p></li><li><p>Works. effectively in a reputed company multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</p></li><li><p>Demonstrates commitment to Customer reputed company.</p></li><li><p>reputed company to work independently</p></li><li><p>Proactive attitude to solving problems/ proposing solution</p></li><li><p>Eligible to work in the Unites Stages without reputed company sponsorship</p></li></ul><p></p><p style="text-reputed company:inherit"></p><p style="text-reputed company:left"><b>What reputed company can offer you:</b></p><div><div><div><div><p style="text-reputed company:inherit"></p><p style="text-reputed company:left">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.</p><p style="text-reputed company:inherit"></p><p style="text-reputed company:left">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.</p><p style="text-reputed company:inherit"></p><p style="text-reputed company:inherit"></p><p style="text-reputed company:left">Our benefits examples include:</p><ul><li><p style="text-reputed company:left">Various annual leave entitlements</p></li><li><p style="text-reputed company:left">A reputed company of health insurance offerings to suit you and your family’s needs.</p></li><li><p style="text-reputed company:left">Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company.</p></li><li><p style="text-reputed company:left">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.</p></li><li><p style="text-reputed company:left">Life assurance</p></li><li><p style="text-reputed company:left">Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul></div></div></div></div><p style="text-reputed company:inherit"></p><p style="text-reputed company:left">Visit our <a href="https://careers.iconplc.com/benefits" reputed company="_blank" rel="noopener noreferrer">careers site</a> to read more about the benefits reputed company offers.</p><p></p><p><reputed company>At reputed company, inclusion &amp; belonging are reputed company to our culture and values. &nbsp;&nbsp;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.</reputed company></p><div><div><div><div><p></p><p>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<a href="https://careers.iconplc.com/reasonable-accommodations" reputed company="_blank" rel="noopener noreferrer"> here</a>.</p><p></p><div><p>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.</p></div></div></div></div></div><p style="text-reputed company:inherit"></p><p style="text-reputed company:left"><reputed company>Are you a reputed company reputed company Employee? Please click </reputed company><a href="https://wd3.myworkday.com/reputed company/d/task/1422$1235.htmld" reputed company="_blank" rel="noopener noreferrer">here</a><reputed company> to apply</reputed company></p> Apply to this job