Clinical Trial Manager II

Job not on LinkedIn

🔥 12 hours ago

⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $72k - $88k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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CPC

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

📦 Logistics

💼 Consulting

Healthcare • Logistics • Consulting

CPC is a trusted tech partner that specializes in IT support and IT services, providing a wide range of solutions including sales and maintenance of new, used, and factory recertified computer hardware and software. Established in 1962, CPC leverages a deep bench of engineers and consultants to offer innovative and efficient IT solutions tailored to both businesses with or without internal IT departments. With a focus on value, innovation, reputation, and excellence, CPC supports various industries including remote work, healthcare, and manufacturing, ensuring businesses stay up, running, and protected. The company partners with leading tech brands such as Citrix, IGEL, LG, Nutanix, Arctic Wolf, NoMachine, Zebra Technologies, and DELL, and offers both new and refurbished equipment. CPC is committed to enhancing business operations through effective IT solutions and services.

📋 Description

• Serve as the primary point of contact for clinical trials site operations. • Serve as the secondary contact for site questions when the site CRA or RA is unavailable. • Ensure CPC SOPs, Good Clinical Practice guidelines, and applicable federal, state, and local regulations are followed. • Review monitoring visit reports and follow-up letters for site evaluation, initiation, routine monitoring, and close-out visits; clarify issues and finalize documentation with CRAs. • Review site-specific Informed Consent Forms and escalate changes for approval as needed. • Provide the Project Manager with site metrics and updates, including enrollment, activations, protocol deviations, monitoring reports, and follow-up letter status. • Maintain site-required records and regulatory documents. • Create and/or review monitoring visit reports, follow-up letter templates, Monitoring Plans, ICF templates, Study Procedure Manuals, source documents, and site newsletters. • Work with CRAs, RAs, and new Clinical Trial Managers on site management and compliance issue resolution. • Oversee Investigational Product release and collection of investigator regulatory documents. • Oversee and approve site activations and IP release. • Participate in project-related and departmental meetings. • Oversee selection of qualified sites and Investigators. • Negotiate study site budgets and oversee site payment tracking and processing with Finance. • Oversee project-specific training of site staff. • Train new Clinical Trial Managers. • Attend project team meetings and provide CRAs with updated study information. • Resolve site issues with other team members. • Conduct drug tracking and disposition. • Oversee remote monitoring. • Keep the Clinical Trial Management System up to date with site trial activities. • Conduct site monitoring or co-monitoring visits as needed.

🎯 Requirements

• Nursing or bachelor’s degree preferred. • A minimum of 3 years of experience in clinical research setting required. • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. • Thorough understanding of the drug development process. • Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint). • Experience with electronic data capture systems. • Excellent interpersonal communication skills, organizational skills and a great attention to detail. • Ability to organize and instruct staff, while promoting group effort and achievement. • Ability to carry out multiple tasks simultaneously. • Ability to complete tasks in an accurate and timely manner. • Ability to manage conflicts and resolve problems effectively. • Ability to discern priorities with minimal direction to accomplish day-to-day tasks. • Willingness to travel up to 25% of the time. • Required to pass a background and education verification check.

🏖️ Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • Flexible and remote work schedules