Clinical Trial Manager II

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

Preferred

• Nursing or bachelor's degree preferred

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
• Academically led clinical research organization and community cardiovascular health programs.
• Aurora, Colorado, USA
• https://cpcclinicalresearch.org/
• Growth Stage
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Qualifications

• 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
• Nursing or bachelor's degree preferred
• A minimum of 3 years of experience in clinical research setting required.

Required skills

• Clinical Research, Clinical Practice (GCP), FDA and ICH Regulations, Drug Development, Microsoft Office Suite

Preferred skills

• Nursing or bachelor's degree preferred

Experience

• 3+ years