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Clinical Operations Manager I

2 months ago

Aurora, Colorado, United States CPC Clinical Research Full time
Job Title: Clinical Operations Manager I

We are seeking a highly skilled Clinical Operations Manager I to join our team at CPC Clinical Research. This role is ideal for an individual who can motivate teams to do great work collaboratively in order to produce the best quality outcomes possible.

Key Responsibilities:
  • Manage site identification and evaluation to ensure compliance with regulatory requirements.
  • Develop or review essential study documents, including protocols, case report forms, and project management plans.
  • Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines.
  • Prepare central IRB submissions and resolve IRB issues.
  • Manage site enrollment and study subject tracking and payments.
  • Assist with the monitoring of project deliverables and project timelines.
  • Develop and distribute project documents, including safety reports, lab reports, and regulatory documents.
  • Identify project-specific training for team members and notify appropriate designees to ensure completion and filing of training documentation.
  • Provide investigational product or device tracking and disposition as required by project.
  • Develop and manage site and vendor contracts, including investigational product supply and electronic data capture system.
  • Track and approve vendor payments.
  • Manage multidisciplinary project team members in relation to their role on assigned projects.
  • Ensure the overall quality of project services and deliverables is maintained.
  • Provide status reports on all projects.
  • Participate in both onsite and offsite investigator meetings and training sessions.
  • Escalate budget, proposals, and change orders discussions to Business Development.
  • Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.
  • Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact.
  • Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files.
  • Schedule project team meetings and prepare meeting agendas and minutes as needed.
  • Perform other non-project related general administrative tasks, such as filing, copying, faxing, and shipping for assigned projects.
  • Cross-train within the project team, as needed.
  • Define and monitor Endpoint and Specialty Services scope, timelines, and deliverables from project initiation to closeout.
  • Provide timely feedback on the progress of project assignments and help assess project issues and propose resolutions to the CPC project lead.
  • Manage contracted deliverables for external committees, including meeting scheduling, generation of meeting minutes, and distribution of meeting materials.
  • Oversee SAE process and assure execution of safety plans.
  • Accurately track receipt, entry, upload, and processing of photos, acetate tracings, and other source documents submitted from sites.
  • Contact appropriate individuals regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.
  • Oversee timely and accurate entry and cleaning of data for all study databases and maintain and file data management documentation as required.
  • Manage the acquisition and supply of project-specific materials to study sites.
  • Provide feedback to study sites on tracing and quality issues, as required by project.
  • Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.
Requirements:
  • Nursing degree or BA/BS in a scientific field (or equivalent knowledge/experience)
  • 3 years of experience in a clinical research setting (required) or 1 year of experience as a Research Assistant (required)
  • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
  • Experience with clinical site startup preferred.
  • Proficiency in Microsoft Office, particularly Outlook, Word, and Excel.
  • Excellent communication and organizational skills.
  • Great attention to detail.
  • Ability to interact with multiple individuals with varied skill sets in a positive, collaborative, and educational manner.
  • Ability to adapt quickly to new situations, manage conflicts, and resolve problems effectively.
  • Willingness to travel up to 25%.

CPC Clinical Research is an equal opportunity employer and welcomes applications from diverse candidates. We offer a comprehensive benefits package, including medical, dental, vision, life, STD, LTD, and 401(k) matching. We also offer 11 paid holidays, vacation days based on years of service, paid sick time, and flexible and remote work schedules.