CPC — ұйымдарға сенімді әрі қауіпсіз технологиялық ортаны сақтауға көмектесетін IT қолдау және қызмет көрсету компаниясы. 1962 жылы құрылған компания инженерлік және консалтингтік тәжірибесін жаңа, пайдаланылған және зауытта қайта сертификатталған компьютерлік жабдықтар мен бағдарламалық жасақтамаға арналған сату, техникалық қызмет көрсету және қолдау қызметтерімен ұштастырады. Оның шешімдері ішкі IT командасы бар немесе жоқ денсаулық сақтау, логистика, консалтинг, қашықтан жұмыс істеу және өндіріс салаларындағы кәсіпорындарға қызмет етеді. CPC Citrix, IGEL, LG, Nutanix, Arctic Wolf, NoMachine, Zebra Technologies және Dell сияқты технология жеткізушілерімен жұмыс істеп, клиенттеріне инфрақұрылым мен жұмыс орны технологияларына арналған практикалық шешімдер ұсынады. Компанияның жұмысқа қабылдау бағыты тиімді IT операциялары мен сенімді техникалық қолдау көрсетуге назар аударатын қызметке бағдарланған команданы көрсетеді.
Clinical Trial Manager II (Remote, Colorado)
Manage clinical trial site operations for CPC, an academic research organization, with responsibility for compliance, monitoring, site activation, investigator records, budgets, and trial metrics.
Сипаттама
- Coordinate clinical trial site operations as the primary contact.
- Back up the site CRA or RA as the contact for site questions when they are unavailable.
- Ensure adherence to CPC SOPs, Good Clinical Practice guidelines, and applicable federal, state, and local regulations.
- Review reports and follow-up letters for site evaluation, initiation, routine monitoring, and close-out visits; resolve questions and finalize documentation with CRAs.
- Review site-specific Informed Consent Forms and escalate proposed changes for approval when needed.
- Update the Project Manager on site metrics, including enrollment, activations, protocol deviations, monitoring reports, and follow-up letter status.
- Maintain required site records and regulatory documentation.
- Create and review monitoring visit reports, follow-up letter templates, Monitoring Plans, ICF templates, Study Procedure Manuals, source documents, and site newsletters.
- Collaborate with CRAs, RAs, and newly hired Clinical Trial Managers to manage sites and resolve compliance issues.
- Oversee Investigational Product release and collection of investigator regulatory documents.
- Oversee and approve site activations and Investigational Product release.
- Attend project and departmental meetings.
- Oversee the selection of qualified sites and investigators.
- Negotiate study site budgets and coordinate site payment tracking and processing with Finance.
- Oversee project-specific training for site staff.
- Train new Clinical Trial Managers.
- Attend project team meetings and share current study information with CRAs.
- Resolve site issues in coordination with other team members.
- Track and manage drug disposition.
- Oversee remote monitoring.
- Keep the Clinical Trial Management System current with site trial activities.
- Conduct site monitoring or co-monitoring visits when needed.
Талаптар
- A nursing or bachelor’s degree is preferred.
- At least three years of experience in a clinical research setting is required.
- Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for clinical drug trials.
- Thorough understanding of the drug development process.
- Proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.
- Experience using electronic data capture systems.
- Strong interpersonal communication and organizational skills, with close attention to detail.
- Ability to organize and instruct staff while encouraging teamwork and shared achievement.
- Ability to manage multiple tasks at once.
- Ability to complete work accurately and on time.
- Ability to manage conflicts and resolve problems effectively.
- Ability to set priorities and complete day-to-day work with minimal direction.
- Willingness to travel up to 25% of the time.
- Must pass background and education verification checks.
Артықшылықтар
- Comprehensive benefits, including medical, dental, vision, life, short-term disability, and long-term disability coverage.
- Dollar-for-dollar 401(k) matching up to 4% of eligible compensation, fully vested immediately.
- 11 paid holidays.
- 15 to 25 vacation days, based on years of service.
- Paid sick time accrued at 2.67 hours every two weeks, up to 80 hours.
- Flexible and remote work schedules.