Clinical Trial Manager I

4 days ago

Aurora, Colorado, United States CPC Clinical Research Full time
Job Description

Job Summary:

CPC Clinical Research is seeking a highly skilled Clinical Trial Manager I to serve as the primary point of contact for clinical trials site operations. As a key member of our team, you will be responsible for ensuring the smooth execution of clinical trials at our partner sites.

Key Responsibilities:

  • Site Operations Management: Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.
  • Regulatory Compliance: Ensure that all site operations are conducted in accordance with CPC SOPs, Good Clinical Practice guidelines, and applicable federal, state, and local regulations.
  • Monitoring Visit Management: 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.
  • Site-Specific Informed Consent Forms (ICFs): Review site-specific ICFs to address site-specific changes and escalate to internal or external parties for approval, as needed.
  • Site Performance Metrics: 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.
  • Record Management: Assure proper maintenance of site-required records for monitoring activities and required regulatory documents per CPC requirements.
  • Study-Specific Materials: 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.
  • Site Management Collaboration: Work with CRAs, RAs, and Clinical Trial Managers on overall site management, including identification, escalation, and resolution of site-related compliance issues.
  • Investigational Product (IP) Management: Support IP release and, once IP release has occurred, work with RAs to collect all new or expiring Investigator regulatory documents.
  • Site Activations and IP Release: Support site activations and IP release.
  • Project Meetings: Participate in project-related and other departmental/CPC meetings as required.
  • Site Selection and Budget Negotiation: Assist with the selection of qualified sites and Investigators for participation in research protocols and assist with negotiation of study site budget.
  • Study Site Payments: Oversee tracking, request, and work with the Finance department on processing study site payments.
  • Study Information Updates: Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring activities.
  • Site Issue Resolution: Work closely with other team members to ensure timely resolution of site issues.
  • Drug Tracking and Disposition: Conduct drug tracking and disposition as required by project.
  • Remote Monitoring: Assist in oversight of remote monitoring.
  • CTMS Management: Ensure the 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.
  • Site Monitoring Visits: Conduct site monitoring visits or co-monitoring visits, as needed.

Requirements:

  • Education: Nursing or bachelor's degree preferred.
  • Experience: A minimum of 2 years of experience in a clinical research setting required, experience in monitoring or clinical trial management preferred.
  • Knowledge and Skills: 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.
  • Personal Qualities: 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.

Benefits:

  • Comprehensive Benefits Package: CPC offers a comprehensive benefits package, including medical, dental, vision, life, STD, LTD, etc.
  • Matching 401(k) Plan: CPC offers a matching 401(k) plan, with dollar-for-dollar matching up to 4% of eligible compensation, fully vested immediately.
  • Paid Holidays: CPC offers 11 paid holidays.
  • Vacation Days: Vacation days based on years of service.
  • Paid Sick Time: Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours).
  • In-Suite Exercise and Relaxation Room: CPC offers an in-suite exercise and relaxation room.
  • Monthly Fun Events: CPC hosts monthly fun events, including team-building activities, games, charitable events, potlucks, and picnics.
  • Flexible and Remote Work Schedules: CPC offers flexible and remote work schedules.

CPC is an Equal Opportunity Employer:

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over, or any other status protected by applicable federal, state, or local law.

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