CPC yra IT palaikymo ir paslaugų įmonė, padedanti organizacijoms palaikyti patikimas ir saugias technologijų aplinkas. 1962 m. įkurta įmonė derina inžinerijos ir konsultavimo kompetenciją su naujos, naudotos ir gamykloje atnaujintos kompiuterinės techninės bei programinės įrangos pardavimu, priežiūra ir palaikymu. Jos sprendimai skirti įmonėms, turinčioms vidines IT komandas arba veikiančioms be jų, sveikatos priežiūros, logistikos, konsultavimo, nuotolinio darbo ir gamybos srityse. CPC bendradarbiauja su tokiais technologijų tiekėjais kaip „Citrix“, „IGEL“, „LG“, „Nutanix“, „Arctic Wolf“, „NoMachine“, „Zebra Technologies“ ir „Dell“, teikdama klientams praktiškus infrastruktūros ir darbo vietų technologijų sprendimus. Įmonės samdos kontekstas atspindi į paslaugas orientuotą komandą, kurios tikslas – užtikrinti efektyvią IT veiklą ir patikimą techninę pagalbą.
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.
Aprašymas
- 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.
Reikalavimai
- 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.
Privalumai
- 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.