Job Summary This position is responsible for overall project and financial management of clinical research and trials throughout the lifespan of the projects. The position's competencies include contract and budget development, and negotiations for clinical trials and grants. Leads and coordinates all of the activities of a multidisciplinary team required for study start up, serves as a clinical research operations liaison with Research Administration, and the research staff, and participates in activities that will help determine study feasibility. The tasks the Clinical Project Manager must be able perform are the ability to problem solve at a strategic level and work well with others to reach solutions, careful planning to achieve accurate and timely results, and the ability to work independently and well under pressure to ensure tasks are prioritized to meet aggressive deadlines . The Clinical Project Manager conducts cost analysis to ensure that the clinical trial is in alignment with the terms of the contract and/or grant, budgets and organization SOPs. This position takes responsibility to plan, communicate, and manage all of the tasks required to conduct clinical research to meet Good Clinical Practices and established milestones. This position reports to the Operations Manager, and works closely with the Clinical Trials Personnel, Legal Counsel, and the Research Administration.
Budget Management: Responsible for detailed budget development for clinical and genomic research, including sponsor and granted-supported budgets. Coordinates and communicates with Research Clinical Teams to ensure budgets are aligned with SHRI's financial goals and objectives. Participates and maintains protocol selection documentation. Accurately identifies standard fees for services guided by Medicare coverage analysis and other regulatory and fair billing practices. Conducts ongoing cost analysis and develops strategies with the Research Clinical Teams, Management and SHRI Finance in order to negotiate and complete competitive rate and determine continued profitability of the trial and or grant Independently, arbitrates and negotiates pricing with sponsors and prepares budget and contract documents for execution. Maintains and monitors all budget requirements through the term of the project including internal cost changes, amendments, and unforeseen study requirements.
Contracting Responsibilities: Reviews all contracts and provides comments and suggestions to Legal Counsel in support of SHRI's safety, clinical, fiscal and regulatory responsibilities. Assures that all applicable Confidentiality Disclosure Agreements, Clinical trial agreements, grant awards and subcontracts agree with final budgets, are appropriately signed and executed prior to scheduled Site Initiation Visits (SIV), IRB approval and grant funding deadlines. Prioritizes responsibilities to meet timeliness required by set initiation and execution dates.
Organizational Pre-Approvals: Performs a pre-review of the study to determine feasibility and the capacity to conduct research at SHRI with the Clinical Research Teams. Utilizes knowledge of clinical operations and good clinical practices to ensure appropriate charges are identified prior to the approval of research at SHRI. Ensures that all Department Managers are fully aware of interdepartmental expectations, and addresses their clinical and research concerns.
Internal Coordination: Coordinates activities of the Clinical Research Teams throughout the term of the project to meet project timelines and sponsor expectations. Makes recommendations to the Research Management Team for cost improvements.
Operational Liaison: Serves as a resource and provides assistance to Research Administration to continually improve processes that supports SHRI's efforts to achieve service excellence and patient satisfaction. Develops effective relationships with pharmaceutical company sponsors and research organizations, focusing on interdisciplinary integration, professionalism and a unified team approach.
Team and Educational Responsibilities: Participates in team committees that will foster educational development and Federal and State regulations applicable to billing, legal and patient care standards. Contributes to the development and implementation of Standard Operating Procedures for the Research Department in alignment with the Code of Federal Regulations, Good Clinical Practices and ICH Guidelines.
Lifecycle Analysis and Change Agent Activity: Serves as liaison with Sponsors and Research Teams to share and distribute information related to all research documentation, including, amendments, change requirements, protocol goals, and grant -related documents throughout the lifecycle of the research projects. Re-evaluates budgets and contracts as they apply to required changes, and assures that all documents are current.
Maintains current research operations and regulatory knowledge through reading publications, and attending appropriate national conferences, subscribing to journals, professional memberships.
Internal Number: 2018-13674
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