Clinical Trial Manager II

CPC Clinical Research • Aurora, CO

1d • $72,000 - $88,000 • Hybrid

About The Position

Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations. In this position, the individual will be responsible for ensuring CPC SOPs, Good Clinical Practice guidelines, and applicable federal, state, and local regulations are followed. This role involves reviewing monitoring visit reports, site-specific Informed Consent Forms (ICFs), and providing project managers with site metrics and updates. The Clinical Trial Manager II will also oversee Investigational Product (IP) release, site activations, and the negotiation and processing of study site budgets and payments. Additionally, the role includes training new Clinical Trial Managers and site staff, conducting site monitoring visits, and ensuring the Clinical Trial Management System (CTMS) is up-to-date.

Requirements

• 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.

Nice To Haves

• Nursing or bachelor’s degree preferred.
• Willingness to travel up to 25% of the time.

Responsibilities

• Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.
• Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.
• Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.
• Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.
• Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.
• Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements.
• Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.
• Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.
• Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.
• Oversee and approve site activations and IP release.
• Participate in project-related and other departmental/CPC meetings as required.
• Oversee the selection of qualified sites and Investigators for participation in research protocols.
• Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.
• Oversee project specific training of site staff.
• Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.
• Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.
• Work closely with other team members to ensure timely resolution of site issues.
• Conduct drug tracking and disposition as required by project.
• Overseeing remote monitoring.
• Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations.
• Conduct site monitoring visits or co-monitoring visits, as needed.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level