Clinical Trial Manager II

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Act as the main contact for operations related to clinical trial sites.

• Function as the secondary contact for site inquiries in the absence of the site CRA or RA.

• Ensure adherence to CPC SOPs, Good Clinical Practice guidelines, and relevant federal, state, and local regulations.

• Review monitoring visit reports and follow-up letters concerning site evaluation, initiation, routine monitoring, and close-out visits; resolve issues and finalize documentation with CRAs.

• Examine site-specific Informed Consent Forms and escalate modifications for approval as necessary.

• Provide the Project Manager with updates and metrics related to the site, including enrollment, activations, protocol deviations, monitoring reports, and the status of follow-up letters.

• Maintain required records and regulatory documents for the site.

• Create and/or 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 new Clinical Trial Managers to manage site operations and resolve compliance issues.

• Supervise the release of Investigational Products and the collection of investigator regulatory documents.

• Oversee and authorize site activations and IP releases.

• Participate in project-related and departmental meetings.

• Manage the selection of qualified sites and Investigators.

• Negotiate study site budgets and oversee the tracking and processing of site payments with Finance.

• Direct project-specific training for site personnel.

• Train new Clinical Trial Managers.

• Attend project team meetings and provide CRAs with updated information regarding the study.

• Address site-related issues alongside other team members.

• Conduct drug tracking and disposition activities.

• Supervise remote monitoring activities.

• Maintain the Clinical Trial Management System with current site trial activities.

• Perform site monitoring or co-monitoring visits as required.

⛳️ Requirements

• Preferred nursing or bachelor’s degree.

• At least 3 years of experience in a clinical research environment is required.

• Comprehensive knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.

• Strong understanding of the drug development process.

• Proficient in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).

• Familiarity with electronic data capture systems.

• Exceptional interpersonal communication abilities, strong organizational skills, and keen attention to detail.

• Capability to organize and guide staff while fostering collaboration and achievement.

• Ability to manage multiple tasks concurrently.

• Competence in completing tasks accurately and promptly.

• Skill in managing conflicts and resolving issues effectively.

• Capacity to prioritize tasks independently to fulfill daily responsibilities.

• Willingness to travel up to 25% of the time.

• Must pass a background and education verification check.

🏝️ Benefits

• Comprehensive benefits package including medical, dental, vision, life insurance, short-term disability, and long-term disability.

• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately).

• 11 paid holidays.

• 15 to 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.