Rachana Kanvinde, MS, SFC, CCRP

Lead strategic trial access and partnership initiatives supporting oncology and advanced programs. Partner with sponsors, advocacy leaders, and cross-functional teams to expand awareness, access, and execution of clinical research initiatives. Provide operational and program leadership across multi-stakeholder initiatives aligned with organizational growth and mission.

Managing the program operations of ACRP Atlanta Area Chapter Inc. in a volunteering leadership role for Association of Clinical Research Professionals (ACRP) organization advancing site excellence, and professional and workforce development.

Managing the Atlanta Area Chapter operations in a volunteering leadership role for Association of Clinical Research Professionals (ACRP) organization.

Led the strategy and oversight of multiple clinical research sites, optimizing operations, accelerating study startup in under 90 days, and expanding access to rare disease and gene therapy trials. Managed operations across 4 sites with oversight of 44 active studies, directing the startup of 7 new trials and activating new sites with staffing, resources, and processes to ensure full integration. Built and implemented SOPs, workflows, and guidance documents to standardize operations, improve quality, and ensure regulatory adherence. Developed and operationalized a gene therapy program, designing specialized workflows and processes to support pharmacy, regulatory, and clinical operations in alignment with advanced therapy requirements. Streamlined processes to shorten cycle times, achieving measurable gains in efficiency and trial delivery. Executed CDAs and negotiated CTAs to secure favorable terms while collaborating with finance on budgets and financial oversight. Represented the organization at major life sciences conferences and exhibits, delivering capabilities presentations to sponsors and CROs, strengthening relationships, and generating new trial opportunities. Led and developed site managers and staff, fostering collaboration, professional growth, and retention through structured training and onboarding. Partnered cross-functionally to deliver compliant, high-quality research outcomes that support organizational and patient-centered goals. Rare Diseases, Gene Therapy, Neuromuscular Diseases, Pediatrics

Served as an advisory board member on the ATHN Community of Practice (CoP) Board providing insights into EDC build and management.

Representing Hemophilia Treatment Center Region 4S (Southeast) as a regional leader in a leadership role for the ATHN Data Management Community of Practice (CoP) Committee.

Led clinical research operations for hem/onc and gene therapy trials, overseeing end-to-end execution of 40+ trials (Phase I-IV) valued at $2M, including IIS global multisite studies. Directed operational strategy, study startup, and compliance oversight for both industry-sponsored and investigator-initiated trials. Optimized protocols, streamlined workflows, and enhanced recruitment by 25% and improved study outcomes. Optimized process improvements by 80% and increased data accuracy by 40%. Built and mentored high-performing research teams (CRCs, coordinators, lab staff) with structured onboarding, competency assessments, and continuous training. Developed SOPs and onboarding strategies improving team retention by 50% and strengthened operational clarity. Contributed to protocol design and translational workflows for early-phase gene therapy trials and first-in-human dosing studies. Passionate about mentorship, I led a high-performing research team, fostering collaboration across investigators, sponsors, and interdisciplinary teams. Pediatrics, Hemophilia, Thrombosis, Immunology, Gene Therapy, Rare Diseases, Translational Science

Managed clinical research programs for pharmaceutical clients and CRO partners, providing oversight of project execution, data integrity, and compliance deliverables. Led research operations and logistics for a portfolio of 25+ Phase I-IV clinical trials across multiple indications, including management of 7 IIS multisite trials, supporting IDE and IND applications valued at up to $700K while ensuring regulatory compliance and trial success. Collaborated with leadership team to define KPIs, study milestones, and operational performance standards. Managed a clinical research team and promoted professional development and enhanced team skills to improve overall performance. Oversaw project timelines, deliverables, and budgets, ensuring milestones were achieved ahead of schedule and within scope. In collaboration with the grants office, reviewed and facilitated study agreements and budgets to ensure alignment with project goals and financial objectives. Strengthened team capabilities and upheld adherence to regulatory guidelines, SOPs, and study objectives by conducting research coordinator trainings. Supported early adoption of technology platforms to streamline monitoring, reporting, and site communication workflows. Leveraging Lean techniques, restructured workflows by developing and implementing project management, communication, and change management plans, streamlining recruitment and scheduling processes while eliminating inefficiencies. Additionally, fostered cross-functional collaboration among diverse research teams to ensure alignment with project timelines and milestones, driving optimal outcomes. Medical Device, Cardiology, Women's Health, Obstetrics, Endocrinology

Led enterprise-level implementation of Cerner's EMR solution across Spectrum Health’s hospital and ambulatory network, supporting clinical integration and operational transformation. Completing the project in 18 months—6 months ahead of schedule—achieving $50K in cost savings and improving operational efficiency. Directed multi-departmental project teams responsible for clinical workflow redesign, data migration, and system configuration. Additionally, streamlined the rollout of the 340B drug pricing program, enhancing cost-effectiveness and optimizing medication procurement. Partnered with physicians, nurses, and administrators to align EMR functionality with clinical operations and patient-care workflows. Managed implementation timelines, resource planning, and vendor coordination to ensure milestones were achieved on schedule and within budget. Developed and delivered end-user training and support programs, enabling smooth adoption and sustained system utilization across hundreds of users. Championed change-management initiatives that improved documentation accuracy, interoperability, and operational efficiency. Provided post-implementation analysis and optimization strategies to refine workflows and enhance data capture for quality reporting.

Supported Physicians and Nurses with workflow and system questions, as part of the Cerner system and CPOE (Computerized Physician Order Entry) implementation. Directed calls to the appropriate analysts for complex build issues during the CPOE Go-Live period and dispatched unit-based rounder's to help physicians who encountered complex patient care workflow scenarios.

Conducted graduate research on c-Met growth factor receptor signaling in prostate cancer, examining its role in tumor metastasis and the phosphorylation dynamics of hepatocyte growth factor (HGF/SF). Applied molecular biology techniques, including adhesion assays, immunoprecipitation, and Western blotting, building a strong scientific foundation that informs later work in gene therapy and clinical research. Oncology, Hematology, Cell & Gene Therapy

Collaborated with faculty to support laboratory operations and research activities. Led the development of a standardized protocol manual for tissue culture coursework, improving student training on laboratory techniques and instrumentation. Spearheaded the design and implementation of a pre-requisite laboratory course for non-science majors, broadening access to foundational scientific education.

Led research on Rho-protein signaling and tumor progression, conducting in vitro and in vivo studies using breast carcinoma (MCF7) models to evaluate Taxol-induced cytotoxicity and apoptosis across cell cycle phases. Applied flow cytometry (BD FACSCalibur) to quantify cellular responses, building a strong foundation in translational oncology research that informs later work in clinical trials. Oncology, Hematology, Immunology, Rare Diseases, Gene Therapy, Cardiology Contributed to translational research applying CRISPR-based gene editing in oncology - breast cancer (BRCA), pancreatic tumors, and non-small cell lung cancer (NSCLC). Supported preclinical studies leveraging genetic re-engineering approaches to evaluate clotting mechanisms in murine models with and without factor infusion, strengthening a foundation in gene therapy and precision medicine that informs later work in clinical research. Oncology, Hematology, Immunology, Rare Diseases, Gene Therapy

-Organized and managed client databases, assembled product management portfolio and provided customer support. -Developed and implemented new product promotions in a support role with the administrative, advertising and marketing departments.

Master’s in Biotechnology with a focus in gene therapy and translational research, with early research and internship experience at the Van Andel Research Institute, Michigan State University, and Grand Valley State University.