Clinical Operations

• 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.

Clinical Operations Manager

• Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency.
• Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.
• Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM).
• Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract.
• Identify the required regulatory documents for investigational product (IP) release and oversee documents collection.
• Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation.
• Oversee the development of project-specific essential documents for site oversight and development of site materials.
• Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs).
• Work with CRAs on overall site management including identification, and resolution of site related compliance issues.
• Prepare study enrollment reports and review site issues with the project team.
• Manage and approve site payments as applicable.
• Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables.
• Define and monitor project scope, timelines and deliverables from project initiation to close-out in collaboration with the Head of Research and Community Health Operations.
• Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.
• Oversee trial-related activities and provide performance feedback to supervisors for all project team members.
• Participate in the review, development and testing of study databases.
• 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.
• Identify vendors and manage vendor services.
• Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, monitoring plans and report templates.
• Develop and manage multidisciplinary project team members.
• Organize, plan for, and produce minutes for project team meetings.
• Proactively identify project issues, propose resolutions to the project team, applicable heads of departments, CPC executives and/or the sponsor, and then track implementation of resolution through to completion and efficacy checks.
• Ensure the overall quality of project services and deliverables.
• Provide necessary updates and reports to the sponsor as outlined by the contract.
• Plan and oversee the execution of investigator meetings as contracted.
• Work with the business development team on budgets, proposals and change orders.
• 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 timely feedback to the Head of Research and Community Health Operations on the progress of project assignments.
• 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.
• Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.
• Supervise and evaluate performance of all staff reporting to this position, if applicable.
• Additional activities as required.

Senior Clinical Operations Manager

Research Scientist

• Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs.
• Based on business needs, may provide assistance to the following functional areas: Research Operations Community Health Endpoint and Specialty Services Site Operations Data Management Quality Control Trial Master File.
• Work closely with other team members to ensure timely completion of deliverables and resolution of issues.
• Perform a variety of general administrative tasks such as filing, copying, and preparation of shipments for assigned projects.
• Upload essential documents into eTMF system.
• Perform quality control reviews of project-specific documentation and support submission of documents to the Trial Master File.
• Assist in sending project supplies to study sites and tracking receipt of those supplies.
• Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing.
• Assist with query management.
• Serve as a study coordinator for select projects as needed.
• Assist with user access requests (including user reconciliation).
• Perform general data review of study data in EDCs.
• Additional activities as required.

Clinical Operations Manager

Senior Clinical Operations Manager

Research Assistant I