Clinical Operations Manager I

We are looking for an experienced Clinical Operations Manager I to join our team!

Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!

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.

In this position you will:

• Manage site identification and evaluation.
• Develop or review essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals.
• Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines and to facilitate approval of investigational product release.
• 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 (e.g. safety reports, lab reports, deviations reports, monitoring reports, follow-up letters, meeting minutes, newsletters, and regulatory documents)
• Identify project-specific training for team members and notify appropriate designee 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 (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services.
• Track and approve vendor payments.
• Manage multidisciplinary project team members in relation to their role on assigned projects. Proactively identify issues and discuss resolutions with applicable department heads, project team, CPC executives and/or the sponsor. Track implementation of resolution through to completion and efficacy checks.
• Ensure that 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. Routinely advise management regarding the overall project status.
• 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, both electronic and paper.
• 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 with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.
• Provide timely feedback on the progress of project assignments; help assess project issues and propose resolutions to the CPC project lead.
• Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to 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 the processing of photos, acetate tracings, and other source documents submitted from sites.
• Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) 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; 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.

Here’s what you will need to bring to the table:

• 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,…