Canopy Cancer Collective, LLC

Compensation

Full Description

Canopy Cancer Collective is a learning health network of leading cancer centers. This first network of 14 NCI-designated cancer centers is dedicated to improving care and outcomes in pancreatic cancer. We connect top medical care providers, cancer researchers, and wellness specialists to formulate and foster best practices. At Canopy Cancer Collective, our mission is to empower pancreatic cancer patients with new hope, treatments, and options. People, not simply their cancer, are at the core of our care. JOB OVERVIEW The Senior Clinical Research Program Manager is responsible for the overall coordination, management, and execution of clinical research programs and projects prioritized by the Canopy Cancer Collective. This role ensures that studies are conducted in compliance with relevant regulations, Good Clinical Practice (GCP) guidelines, and organizational policies. The Program Manager works closely with Principal Investigators (PIs) from across the Canopy network, study teams, sponsors, and other stakeholders to facilitate the successful selection, start up and completion of clinical research and quality improvement projects from initiation to close-out. The Clinical Research Program Manager plays an important role in identifying and implementing new research policies, processes, and procedures. This position reports to the Executive Director. RESPONSIBILITIES Program and Project Management: • Oversee and manage multiple clinical research studies. • Develop and maintain project plans, timelines, and budgets. • Monitor project progress, identify potential risks and issues, and implement mitigation strategies. • Collaborate with the Canopy Cancer Collective Research Governance Committee and the Canopy network to ensure efficient funding and resource allocation across studies. • Serve as a central point of contact for all study-related activities. • Provide direction and administrative support to the Canopy Research Governance Committee. Study Initiation and Planning: • Collaborate with PIs in the development of study protocols, informed consent forms, and other study-related documents. • Assist with budget development for research projects. • Manage the regulatory submission process, including IRB applications and approvals. • Coordinate site selection and feasibility assessments. • Plan and execute study start-up activities, including site initiation visits and training. Study Conduct and Monitoring: • Ensure adherence to study protocols, GCP guidelines, and relevant regulations. • Develop and implement study-specific procedures and tools. • Assist in the design of Case Report Forms (CRFs) • Oversee data collection, management, and quality control processes. • Coordinate communication between study sites, sponsors, and the study team. • Manage and track study supplies and equipment. • Facilitate monitoring visits and address any findings. • Maintain accurate and complete study documentation (e.g., study files, regulatory binders). Financial Management: • Develop and manage study budgets, track expenses, and ensure financial accountability. • Process invoices and payments related to research activities. • Collaborate with finance departments and sponsors on budget reconciliation. Regulatory Compliance: • Maintain a thorough understanding of applicable local, state, and federal regulations, GCP guidelines, and institutional policies. • Ensure that all research activities are conducted in compliance with these requirements. • Manage the preparation and submission of regulatory documents, including amendments and safety reports. • Coordinate and prepare for audits and inspections. Team Leadership and Collaboration: • Conduct regular team meetings and provide updates on study progress. • Liaise with Canopy network sites, partners, and external collaborators (e.g., sponsors, CROs). Data Management and Reporting: • Oversee the collection, cleaning, and storage of study data. • Generate reports on study progress, enrollment, and data quality. • Assist with data analysis and the preparation of manuscripts and presentations. Quality Assurance: • Implement quality control measures to ensure the integrity and accuracy of research data. • Participate in quality improvement initiatives. • Develop and maintain Standard Operating Procedures (SOPs) related to clinical research activities. QUALIFICATIONS • Background in scientific research or clinical research methodologies is required, experience in clinical trial highly desirable. • Strong knowledge of compliance management practices within the context of clinical research. • Experience supervising staff in a laboratory or clinical setting is preferred. • Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements related to clinical trials. • Demonstrated project management skills with a track record of successfully delivering projects on time. • High visibility projects • Proven ability to collaborate effectively with physicians and healthcare executives to influence clinical decision-making and operational procedures • Excellent organizational skills with the ability to manage multiple priorities simultaneously. • Strong analytical skills for data collection and interpretation related to clinical outcomes is highly desirable. This position offers an exciting opportunity for individuals passionate about advancing healthcare through research driven opportunities in a dynamic environment. Job Type: Full-time Pay: $125,000.00 - $150,000.00 per year Application Question(s): • Please describe how your experience meets the qualifications for this role. Highlight any clinical healthcare research project management experience Work Location: Remote